Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00101686
Registration number
NCT00101686
Ethics application status
Date submitted
12/01/2005
Date registered
13/01/2005
Date last updated
12/01/2010
Titles & IDs
Public title
Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.
Query!
Scientific title
A Randomized, Multi-Center Phase III Trial Of Irinotecan In Combination With Three Different Methods Of Administration Of Fluoropyrimidine: Infusional 5-FU (FOLFIRI), Modified-Bolus 5-FU (Day 1 & 8), And Oral Capecitabine (Day 1-14); With Celecoxib Versus Placebo As First-Line Treatment For Patients With Metastatic Colorectal Cancer Study Amended April 23, 2004 To Include Bevacizumab
Query!
Secondary ID [1]
0
0
A5961021
Query!
Secondary ID [2]
0
0
CPTAIV-0020-411
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Modified Bolus 5-FU/LV with Irinotecan
Treatment: Drugs - FOLFIRI + bevacizumab
Treatment: Drugs - miFL + bevacizumab
Treatment: Drugs - Infusional 5-FU/LV with Irinotecan
Treatment: Drugs - Oral Capecitabine with Irinotecan
Experimental: Modified Bolus 5-FU/LV with Irinotecan -
Experimental: FOLFIRI + bevacizumab -
Experimental: miFL + bevacizumab -
Experimental: Infusional 5-FU/LV with Irinotecan -
Other: Oral Capecitabine with Irinotecan -
Treatment: Drugs: Modified Bolus 5-FU/LV with Irinotecan
Day 1 & 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID [two times a day] (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
Treatment: Drugs: FOLFIRI + bevacizumab
Day 1 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
I m m e d i a t e l y f o l l o w e d b y :
5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Every 2 weeks
Amendment 2 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
I m m e d i a t e l y f o l l o w e d b y :
5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Celecoxib/placebo 400 mg BID [two times a day] oral Every 2 weeks
Treatment: Drugs: miFL + bevacizumab
Day 1 Bevacizumab 7.5mg/kg IV *over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Every 3 weeks Amendment 2 Day 1 Bevacizumab 7.5mg/kg IV over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo 400 mg BID [two times a day] oral Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo -- 400 mg po BID [two times a day] continues daily without interruption Every 3 weeks
Treatment: Drugs: Infusional 5-FU/LV with Irinotecan
Day 1: Irinotecan (180 mg/m2) IV over 90 minutes, LV (racemic mixture 400 mg/m2) over 2 hours during irinotecan infusion but without mixing, immediately followed by 5-FU IV bolus (400 mg/m2) and 5-FU continuous infusion (2400 mg/m2) over 46 hours. FOLFIRI regimen is repeated every 2 weeks. Celecoxib/placebo treatment will commence on the same day at a dose of 400 mg po BID [two times a day](800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
Treatment: Drugs: Oral Capecitabine with Irinotecan
Day 1: Irinotecan (250 mg/m2 IV) over 90 minutes; Day 1-14: capecitabine 1000 mg/m2 PO BID [two times a day] (28 single doses). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL
Query!
Assessment method [1]
0
0
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Query!
Timepoint [1]
0
0
every 6 weeks until disease progression
Query!
Secondary outcome [1]
0
0
Time to Progression: FOLFIRI, mIFL and CapeIRI
Query!
Assessment method [1]
0
0
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Query!
Timepoint [1]
0
0
every 6 weeks until disease progression
Query!
Secondary outcome [2]
0
0
Overall Response: FOLFIRI, mIFL and CapeIRI
Query!
Assessment method [2]
0
0
A subject will be considered achieving an overall response if the subject has a sustained Complete Response (CR) or Partial Response (PR) for at least 4 weeks, confirmed by tumor assessments. (CR: Disappearance of all target lesions. PR: greater than or equal to 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Pre-treatment sum LD. )
Query!
Timepoint [2]
0
0
every 6 weeks during chemotherapy until disease progression
Query!
Secondary outcome [3]
0
0
Survival Time: FOLFIRI, mIFL and CapeIRI
Query!
Assessment method [3]
0
0
Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Query!
Timepoint [3]
0
0
assessed at least every week during treatment and at least every 3 months during follow-up
Query!
Secondary outcome [4]
0
0
1 Year Survival: FOLFIRI, mIFL and CapeIRI
Query!
Assessment method [4]
0
0
Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Query!
Timepoint [4]
0
0
1 year from date of randomization
Query!
Secondary outcome [5]
0
0
Time to Progression : Celecoxib and Placebo
Query!
Assessment method [5]
0
0
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Query!
Timepoint [5]
0
0
every 6 weeks until disease progression
Query!
Secondary outcome [6]
0
0
Overall Response: Celecoxib and Placebo
Query!
Assessment method [6]
0
0
A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): = 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )
Query!
Timepoint [6]
0
0
every 6 weeks during chemotherapy until disease progression
Query!
Secondary outcome [7]
0
0
Survival Time: Celecoxib and Placebo
Query!
Assessment method [7]
0
0
Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Query!
Timepoint [7]
0
0
assessed at least every week during treatment and at least every 3 months during follow-up
Query!
Secondary outcome [8]
0
0
Time to Progression: Bevacizumab With FOLFIRI, mIFL
Query!
Assessment method [8]
0
0
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Query!
Timepoint [8]
0
0
every 6 weeks until disease progression
Query!
Secondary outcome [9]
0
0
Overall Response: Bevacizumab With FOLFIRI, mIFL
Query!
Assessment method [9]
0
0
A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): = 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )
Query!
Timepoint [9]
0
0
every 6 weeks during chemotherapy until disease progression
Query!
Secondary outcome [10]
0
0
1 Year Survival: Bevacizumab With FOLFIRI, mIFL
Query!
Assessment method [10]
0
0
Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Query!
Timepoint [10]
0
0
1 year from date of randomization
Query!
Secondary outcome [11]
0
0
Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL
Query!
Assessment method [11]
0
0
Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. Zero subjects analyzed indicates median could not be analyzed based on number of subjects who died.
Query!
Timepoint [11]
0
0
Last Follow-Up Visit
Query!
Secondary outcome [12]
0
0
Dose Reduction Due to Treatment Emergent Adverse Events
Query!
Assessment method [12]
0
0
Number of subjects that had at least one Treatment-Emergent Adverse Event (TEAE) that led to a dose reduction. TEAE includes all reported Adverse Events that occurred within 30 days of last study medication.
Query!
Timepoint [12]
0
0
Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI
Query!
Secondary outcome [13]
0
0
Overall Relative Dose Intensity of Irinotecan
Query!
Assessment method [13]
0
0
Relative dose intensity for a cycle was calculated as the percentage of the actual dose intensity of the cycle divided by the planned dose intensity of the cycle. Overall relative dose intensity was calculated as the average relative dose intensities over all cycles. (Dose intensity for each cycle was calculated as the actual dose level of the study medication received in that cycle divided by the number of weeks in the cycle.)
Query!
Timepoint [13]
0
0
End of treatment cycle
Query!
Eligibility
Key inclusion criteria
- Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with
evidence of metastatic disease. (Stage IV distant disease)
- Present or past histological documentation of adenocarcinoma of the colon or rectum.
The site of the primary lesion must be or have been confirmed endoscopically,
radiologically, or surgically to be or have been in the large bowel. Patients with a
history of colorectal cancer treated by surgical resection who develop radiological or
clinical evidence of metastatic cancer do not require separate histological or
cytological confirmation of metastatic disease unless:
- An interval of greater than five years has elapsed between the primary surgery and the
development of metastatic disease.
- The primary cancer was a Duke's A or B1.
- Physicians should consider biopsy of lesions to establish the diagnosis of metastatic
colorectal cancer in each case if there is substantial clinical ambiguity regarding
the nature of source of apparent metastases.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Patients who received any prior systemic anticancer therapy for metastatic colorectal
cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine
therapy, cytokine therapy, or other experimental agents).
- Patients cannot have concurrent malignancies at study entry.
- Exceptions: Patients with prior non-colorectal malignancies will be eligible if they
have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their
treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer).
Patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer
that have been effectively treated are eligible, even if these were diagnosed within 3
years before randomization.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2003
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/10/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
547
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Pfizer Investigational Site - Waratah
Query!
Recruitment hospital [2]
0
0
Pfizer Investigational Site - South Brisbane
Query!
Recruitment hospital [3]
0
0
Pfizer Investigational Site - Bedford Park
Query!
Recruitment hospital [4]
0
0
Pfizer Investigational Site - Woodville
Query!
Recruitment hospital [5]
0
0
Pfizer Investigational Site - Clayton
Query!
Recruitment hospital [6]
0
0
Pfizer Investigational Site - Frankston
Query!
Recruitment postcode(s) [1]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [2]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [3]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [4]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [5]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [6]
0
0
3199 - Frankston
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
District of Columbia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Florida
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Georgia
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Illinois
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Indiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Louisiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maine
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Maryland
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Massachusetts
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Michigan
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Minnesota
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Missouri
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Montana
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Nebraska
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Nevada
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New Hampshire
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
New Jersey
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
New Mexico
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
New York
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
North Carolina
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Ohio
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Oklahoma
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Oregon
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Pennsylvania
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Tennessee
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Texas
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Vermont
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Virginia
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Washington
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Wisconsin
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
New Brunswick
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Newfoundland and Labrador
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Nova Scotia
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Ontario
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Quebec
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Saskatchewan
Query!
Country [44]
0
0
New Zealand
Query!
State/province [44]
0
0
Auckland
Query!
Country [45]
0
0
New Zealand
Query!
State/province [45]
0
0
Dunedin
Query!
Country [46]
0
0
New Zealand
Query!
State/province [46]
0
0
Riccarton
Query!
Country [47]
0
0
New Zealand
Query!
State/province [47]
0
0
Wellington
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study compares in the first study period combination of Irinotecan with three different
methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second
period of study it compares FOLFIRI [a chemotherapy regime that combines bolus irinotecan and
leucovorin [LV] with infusional 5-fluorouracil (5-FU)] + bevacizumab and mlFL + bevacizumab.
Measures of efficacy and safety will be reported.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00101686
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00101686
Download to PDF