Randomized, Phase 2 Study of FOLFOX or FOLFIRI with AG-013736 or Bevacizumab in Patients with Metastatic Colorectal Cancer after Failure of an Irinotecan or Oxaliplatin-containing First-line Regimen

Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA0 sites176 target enrollmentMay 9, 2008

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Second line treatment of patients with metastatic carcinoma of colon and rectum
Sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA
Enrollment: 176
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

May 9, 2008

End Date

April 12, 2012

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA

•1\. Histologically\-documented metastatic CRC plus any one of the following:
•\- Failure of one prior irinotecan\- or oxaliplatin\-containing regimen documented with radiographic evidence of disease progression as defined by RECIST criteria and documented with 2 sets of CT/MRI scans during irinotecan or oxaliplatin therapy or within 6 months after the last dose of the irinotecan\- or oxaliplatin\-containing regimen (patients with prior adjuvant chemotherapy or radiation therapy are eligible); or
•\- Intolerance to prior oxaliplatin therapy, defined as occurrence of Grade 3 or 4 neurotoxicity that is persistent between cycles.
•2\. Adequate organ function, as defined by the following criteria:
•\- Absolute neutrophil count (ANC) \=1500 cells/mm3
•\- Platelets \=100,000 cells/mm3
•\- Hemoglobin \=9\.0 g/dL
•\- Total serum bilirubin \=1\.5 times upper limit of normal (x ULN)
•\- AST and ALT \=2\.5 x ULN, or AST and ALT \=5 x ULN if liver function abnormalities are due to underlying malignancy
•\- Serum creatinine \=1\.5 x ULN

•1\. Prior treatment of metastatic CRC with more than 1 systemic chemotherapy regimen for metastatic disease. Patients who participated in study A4061020 are not eligible to participate in this study.
•2\. Prior irradiation to \=25% of the bone marrow (whole pelvis \=25%; a patient with prior whole pelvis irradiation is ineligible).
•3\. Pleural effusion or ascites that causes \= Grade 2 dyspnea.
•4\. Current use or anticipated need for food or drugs that are known cytochrome P450 (CYP) 3A4 inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, itraconazole, erythromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, and delavirdine) during the course of the study
•5\. Current use or anticipated need for drugs that are known CYP3A4 or CYP1A2 inducers (i.e., carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, and St John's wort) during the course of study (Note: the short\-term use of dexamethasone as a premedication for chemotherapy is not an exclusion criterion)
•6\. History of hemoptysis \> ½ tsp of bright red blood in one day within past 1 week.
•7\. Patients with active seizure disorder or brain metastases
•8\. Gastrointestinal abnormalities including:
•\- inability to take oral medication
•\- requirement for intravenous alimentation