EUCTR2007-006283-30-IT
Active, not recruiting
Not Applicable
A RANDOMIZED, PHASE 2 STUDY OF FOLFOX OR FOLFIRI WITH AG-013736OR BEVACIZUMAB IN PATIENTS WITH METASTATIC COLORECTALCANCER AFTER FAILURE OF AN IRINOTECAN OR OXALIPLATINCONTAININGFIRST-LINE REGIMEN - ND
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- PFIZER
- Enrollment
- 176
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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);
- •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 AST and ALT abnormalities are due to underlying malignancy
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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