You are here

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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
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.

NCT00615056
Pfizer
Completed
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Breast Neoplasms
NCT01176916
Females
0+
Years
Multiple Sites
Non-Small-Cell Lung Carcinoma, Lung Neoplasms
NCT00063219
All Genders
18+
Years
Multiple Sites
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
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Neoplasms
  • 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.
  • 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])
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
April 2012
March 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Italy,   Japan,   Korea, Republic of,   Poland,   Spain,   United States
Belgium,   Czech Republic
 
NCT00615056
A4061034
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now