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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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.
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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
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Secondary ID [1]
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A5961021
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Secondary ID [2]
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CPTAIV-0020-411
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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:
Colorectal Neoplasms
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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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).
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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 Progression (TTP) at Primary Completion: FOLFIRI and mIFL
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Assessment method [1]
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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).
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Timepoint [1]
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every 6 weeks until disease progression
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Secondary outcome [1]
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Time to Progression: FOLFIRI, mIFL and CapeIRI
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Assessment method [1]
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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).
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Timepoint [1]
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every 6 weeks until disease progression
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Secondary outcome [2]
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Overall Response: FOLFIRI, mIFL and CapeIRI
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Assessment method [2]
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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. )
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Timepoint [2]
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every 6 weeks during chemotherapy until disease progression
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Secondary outcome [3]
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Survival Time: FOLFIRI, mIFL and CapeIRI
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Assessment method [3]
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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.
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Timepoint [3]
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assessed at least every week during treatment and at least every 3 months during follow-up
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Secondary outcome [4]
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1 Year Survival: FOLFIRI, mIFL and CapeIRI
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Assessment method [4]
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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.
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Timepoint [4]
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1 year from date of randomization
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Secondary outcome [5]
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Time to Progression : Celecoxib and Placebo
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Assessment method [5]
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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).
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Timepoint [5]
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every 6 weeks until disease progression
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Secondary outcome [6]
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Overall Response: Celecoxib and Placebo
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Assessment method [6]
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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. )
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Timepoint [6]
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every 6 weeks during chemotherapy until disease progression
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Secondary outcome [7]
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Survival Time: Celecoxib and Placebo
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Assessment method [7]
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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.
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Timepoint [7]
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assessed at least every week during treatment and at least every 3 months during follow-up
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Secondary outcome [8]
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Time to Progression: Bevacizumab With FOLFIRI, mIFL
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Assessment method [8]
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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).
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Timepoint [8]
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every 6 weeks until disease progression
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Secondary outcome [9]
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Overall Response: Bevacizumab With FOLFIRI, mIFL
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Assessment method [9]
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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. )
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Timepoint [9]
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every 6 weeks during chemotherapy until disease progression
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Secondary outcome [10]
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1 Year Survival: Bevacizumab With FOLFIRI, mIFL
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Assessment method [10]
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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.
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Timepoint [10]
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1 year from date of randomization
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Secondary outcome [11]
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Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL
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Assessment method [11]
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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.
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Timepoint [11]
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Last Follow-Up Visit
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Secondary outcome [12]
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Dose Reduction Due to Treatment Emergent Adverse Events
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Assessment method [12]
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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.
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Timepoint [12]
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Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI
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Secondary outcome [13]
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Overall Relative Dose Intensity of Irinotecan
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Assessment method [13]
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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.)
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Timepoint [13]
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End of treatment cycle
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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.
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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
* 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.
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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
Parallel
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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
1/02/2003
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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
1/10/2008
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Sample size
Target
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Accrual to date
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Final
547
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - Waratah
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Recruitment hospital [2]
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Pfizer Investigational Site - South Brisbane
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Pfizer Investigational Site - Bedford Park
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Recruitment hospital [4]
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Pfizer Investigational Site - Woodville
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Recruitment hospital [5]
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Pfizer Investigational Site - Clayton
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Recruitment hospital [6]
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Pfizer Investigational Site - Frankston
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Recruitment postcode(s) [1]
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2298 - Waratah
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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5042 - Bedford Park
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Recruitment postcode(s) [4]
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5011 - Woodville
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3199 - Frankston
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Colorado
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Connecticut
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Riccarton
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New Zealand
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00101686
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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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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for public queries
Name
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00101686
Download to PDF