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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00191152
Registration number
NCT00191152
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
24/12/2009
Titles & IDs
Public title
A Phase III Trial For Patients With Metastatic Breast Cancer
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Scientific title
Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd
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Secondary ID [1]
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B9E-US-S188
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Secondary ID [2]
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4703
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Breast Neoplasms
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Cancer of the Breast
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - gemcitabine
Treatment: Drugs - docetaxel
Treatment: Drugs - capecitabine
Experimental: Gemcitabine + Docetaxel -
Active Comparator: Capecitabine + Docetaxel -
Treatment: Drugs: gemcitabine
1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression
Treatment: Drugs: docetaxel
75 mg/m2, intravenous (IV), every 21 days until disease progression
Treatment: Drugs: capecitabine
1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Disease Progression (Initial Treatment)
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Assessment method [1]
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Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.
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Timepoint [1]
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Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)
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Secondary outcome [1]
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Time to Disease Progression (Crossover Treatment)
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Assessment method [1]
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For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression.
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Timepoint [1]
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Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)
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Secondary outcome [2]
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Progression-Free Survival (Initial Treatment)
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Assessment method [2]
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For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment.
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Timepoint [2]
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Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)
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Secondary outcome [3]
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Progression-Free Survival (Crossover Treatment)
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Assessment method [3]
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For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression.
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Timepoint [3]
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First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)
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Secondary outcome [4]
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Duration of Response (Initial Treatment)
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Assessment method [4]
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Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment.
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Timepoint [4]
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Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)
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Secondary outcome [5]
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Duration of Response (Crossover Treatment)
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Assessment method [5]
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At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over & achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression.
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Timepoint [5]
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Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)
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Secondary outcome [6]
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Overall Survival
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Assessment method [6]
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Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive.
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Timepoint [6]
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Date of randomization to date of death from any cause (up to 82 months)
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Secondary outcome [7]
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Best Overall Response (Initial Treatment)
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Assessment method [7]
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Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.
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Timepoint [7]
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Best response from start of treatment until disease progression/recurrence (up to 82 months)
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Secondary outcome [8]
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Best Overall Response (Crossover Treatment)
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Assessment method [8]
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Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using RECIST criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.
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Timepoint [8]
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Best response from start of treatment until disease progression/recurrence (up to 82 months)
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Secondary outcome [9]
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Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)
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Assessment method [9]
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KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).
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Timepoint [9]
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Baseline until crossover treatment began (up to 82 months)
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Secondary outcome [10]
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Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)
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Assessment method [10]
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KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).
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Timepoint [10]
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First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)
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Secondary outcome [11]
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Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)
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Assessment method [11]
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RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].
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Timepoint [11]
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Baseline until crossover treatment began (up to 82 months)
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Secondary outcome [12]
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Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)
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Assessment method [12]
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RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].
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Timepoint [12]
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First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)
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Eligibility
Key inclusion criteria
- Histologic or cytologic confirmation of breast cancer with locally advanced and/or
metastatic disease
- Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it
has been greater than or equal to 6 months since completion of the regimen
- Patients may have had 0-1, but no more than one prior course of chemotherapy for
metastatic disease
- Patients must have either measurable or non-measurable (evaluable) disease
- Prior radiation therapy allowed of less than 25% of the bone marrow
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Second primary malignancy (except in situ carcinoma of the cervix or adequately
treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5
years previously with no evidence of recurrence)
- Parenchymal or leptomeningeal brain metastases
- Peripheral neuropathy greater than or equal to grade 2
- Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment
with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in
the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than
or equal to 6 months prior to enrollment.
- Active cardiac disease not controlled by therapy and/or myocardial infarction within
the preceding 6 months.
- Concomitant Herceptin is not allowed
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2008
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Sample size
Target
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Accrual to date
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Final
475
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. - Waratah
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Recruitment hospital [2]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. - Redcliffe
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Recruitment hospital [3]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. - Ashford
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Recruitment postcode(s) [1]
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- Waratah
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Recruitment postcode(s) [2]
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- Redcliffe
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Recruitment postcode(s) [3]
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- Ashford
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Idaho
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Indiana
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Iowa
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Kentucky
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United States of America
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Louisiana
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Michigan
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Missouri
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Nebraska
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New Jersey
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New York
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Wisconsin
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Argentina
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Capital Federal
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Argentina
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Mendoza
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Argentina
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Rosario
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Argentina
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Santa Fe
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Brazil
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Porto Alegre
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Korea, Republic of
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Seoul
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Mexico
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Acapulco
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Mexico
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Mexico City
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Mexico
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Michoacan
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Mexico
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Toluca
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Puerto Rico
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San Juan
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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State/province [37]
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Tao-Yuan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/
capecitabine doublets, with crossover to the alternate agent. The experimental arm will
receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75
mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive
docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1
through 14 repeated every three weeks. Patients who progress on the experimental arm, will be
treated with capecitabine as dosed on the comparator arm. Patients who progress on the
comparator arm will be treated with gemcitabine as dosed on the experimental arm.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00191152
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Country
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00191152
Download to PDF