A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen

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NCT00615056

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Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically documented colorectal cancer plus one of the following:

- Failure of one prior irinotecan- or oxaliplatin-containing regimen, or

- Adjuvant refractory to irinotecan- or oxaliplatin-containing regimen.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior treatment in first line metastatic setting with more than one regimen


- Prior irradiation of more than 25% of bone marrow.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen
Official Title  ICMJE A Randomized, Phase 2 Study Of FOLFOX Or FOLFIRI With AG-013736 Or Bevacizumab (Avastin) In Patients With Metastatic Colorectal Cancer After Failure Of An Irinotecan Or Oxaliplatin-Containing First-Line Regimen
Brief Summary The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE
  • Drug: Bevacizumab (avastin)
    Bevacizumab intravenous [IV] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
  • Drug: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])
    Irinotecan (180 mg/m²) intravenous infusion [IV] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous [IV] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
  • Drug: AG-013736 (axitinib)
    Axitinib is given at a starting dose of 5 mg twice daily [BID] continuous dosing until disease progression, intolerance or withdrawal of consent.
  • Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
    Oxaliplatin (85 mg/m²) intravenous infusion [IV] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
  • Drug: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])
    Irinotecan (180 mg/m²) intravenous infusion [IV] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) IV and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
  • Drug: Bevacizumab (avastin)
    Bevacizumab intravenous infusion [IV] 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
  • Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
    Oxaliplatin (85 mg/m²) IV infusion over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
Study Arms  ICMJE
  • Active Comparator: B
    Bevacizumab (avastin)
    Interventions:
    • Drug: Bevacizumab (avastin)
    • Drug: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])
  • Experimental: C
    AG-013736 (axitinib)
    Interventions:
    • Drug: AG-013736 (axitinib)
    • Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
  • Experimental: A
    AG-013736 (axitinib)
    Interventions:
    • Drug: AG-013736 (axitinib)
    • Drug: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])
  • Active Comparator: D
    bevacizumab (avastin)
    Interventions:
    • Drug: Bevacizumab (avastin)
    • Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2011)		171
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2008)		176
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically documented colorectal cancer plus one of the following:
  • Failure of one prior irinotecan- or oxaliplatin-containing regimen, or
  • Adjuvant refractory to irinotecan- or oxaliplatin-containing regimen.

Exclusion Criteria:

  • Prior treatment in first line metastatic setting with more than one regimen
  • Prior irradiation of more than 25% of bone marrow.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Italy,   Japan,   Korea, Republic of,   Poland,   Spain,   United States
Removed Location Countries Belgium,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00615056
Other Study ID Numbers  ICMJE A4061034
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP