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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/NCT00085332
Registration number
NCT00085332
Ethics application status
Date submitted
10/06/2004
Date registered
11/06/2004
Date last updated
13/01/2014
Titles & IDs
Public title
Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)
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Scientific title
A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
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Secondary ID [1]
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CDR0000368634
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Secondary ID [2]
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GOG-0129N
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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:
Endometrial Cancer
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - docetaxel
Treatment: Drugs: docetaxel
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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
Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed endometrial carcinoma
- Recurrent or persistent disease
- Refractory to curative or standard therapy
- Measurable disease
- At least 1 unidimensionally measurable lesion = 20 mm by conventional techniques
OR = 10 mm by spiral CT scan
- At least 1 target lesion
- Tumors within a previously irradiated field are not considered target
lesions
- Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose,
consolidation, or extended therapy administered after surgical or non-surgical
assessment
- One additional non-cytotoxic regimen for recurrent or persistent disease allowed,
including monoclonal antibodies, cytokines, and small-molecule inhibitors of
signal transduction
- Ineligible for a higher priority GOG protocol
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count = 1,500/mm^3
- Platelet count = 100,000/mm^3
Hepatic
- SGOT = 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase = 2.5 times ULN
- Bilirubin = 1.5 times ULN
Renal
- Creatinine = 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No neuropathy (sensory and motor) = grade 2
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 3 weeks since prior biologic or immunologic therapy for malignant tumor
- No concurrent prophylactic growth factors
- No concurrent prophylactic thrombopoietic agents
Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
- No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic
drugs)
Endocrine therapy
- At least 1 week since prior hormonal therapy for malignant tumor
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
Surgery
- Recovered from prior surgery
Other
- At least 3 weeks since other prior therapy for malignant tumor
- No prior anticancer therapy that would preclude current protocol therapy
- No concurrent amifostine or other protective reagents
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
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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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Intervention assignment
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Other design features
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Phase
Phase 2
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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
1/07/2004
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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
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Sample size
Target
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Australia New Zealand Gynaecological Oncology Trials Group - Camperdown
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Recruitment postcode(s) [1]
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1450 - Camperdown
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Recruitment outside Australia
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United States of America
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Alabama
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Kagoshima City
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Norway
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Oslo
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Funding & Sponsors
Primary sponsor type
Other
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Name
Gynecologic Oncology Group
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Address
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop
tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with
recurrent or persistent endometrial carcinoma (cancer).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00085332
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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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Agustin Garcia, MD
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Address
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Premiere Oncology
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00085332
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