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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Colorectal Neoplasms

Treatments: Drug: Bevacizumab (avastin); Drug: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]); Drug: AG-013736 (axitinib); Drug: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU]); Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Study type: Interventional

Funder types: Industry

Identifiers

NCT00615056

A4061034

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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171 participants in 4 patient groups

B

Active Comparator group

Description:

Bevacizumab (avastin)

Treatment:

Drug: Bevacizumab (avastin)

Drug: Bevacizumab (avastin)

Drug: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])

C

Experimental group

Description:

AG-013736 (axitinib)

Treatment:

Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Drug: AG-013736 (axitinib)

Drug: AG-013736 (axitinib)

A

Experimental group

Description:

AG-013736 (axitinib)

Treatment:

Drug: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])

Drug: AG-013736 (axitinib)

Drug: AG-013736 (axitinib)

D

Active Comparator group

Description:

bevacizumab (avastin)

Treatment:

Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Drug: Bevacizumab (avastin)

Drug: Bevacizumab (avastin)