Study of Bevacizumab/mFOLFOX6 Versus Bevacizumab/Folfiri With Biomarker Stratification in Patients With Previously Untreated Metastatic Colorectal Cancer
Basic Trial Information
|Phase II||Treatment||Closed||18 and over||Pharmaceutical / Industry||ML25710|
This will be a randomized, open-label, multicenter, phase II study. The study p opulation will consist of first-line metastatic colorectal cancer patients.
- Histologically or cytologically confirmed colorectal cancer (CRC) with at least one measurable metastatic lesion by RECIST, v1.1
- Archival tumor tissue sample for ERCC-1 assessment (stratification) must be requested and available prior to study entry. If no archival tumor tissue sample is available, a fresh biopsy tissue sample must be obtained but should be discussed first with the medical monitor. A copy of the local pathology report must be submitted along with the specimens.
- Patients with treated brain metastases are eligible for study participation. Patients may not receive ongoing treatment with steroids at screening. Anticonvulsants (at stable dose) are allowed. Treatment for brain metastases may be whole-brain radiotherapy, radiosurgery, neurosurgery, or a combination as deemed appropriate by the treating physician. Radiotherapy and stereotactic radiosurgery must be completed at least 28 days prior to randomization.
- Female patients should not be pregnant or breast-feeding. Female patients with childbearing potential should agree to use effective, non-hormonal means of contraception during the study and for a period of at least 6 months following the last administration of study drugs. Female patients with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the study.
- Male patients must agree to use effective contraception during the study and for a period of at least 6 months following the last administration of study drugs, even if they have been surgically sterilized
- Any prior systemic treatment for metastatic CRC
- Adjuvant chemotherapy for CRC completed < 12 months
- Evidence of Gilbert's Syndrome or of homozygosity for the UGT1A1*28 allele
- Known positivity for human immunodeficiency virus (HIV)
- Malignancies other than metastatic CRC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
- Radiotherapy to any site for any reason within 28 days prior to randomization, except for palliative radiotherapy to bone lesions within 14 days prior to randomization
- Clinically detectable third-space fluid collections that cannot be controlled by drainage or other procedures prior to study entry
- Treatment with any other investigational agent, or participation in another investigational drug trial within 28 days prior to randomization
Trial Contact Information
Trial Lead Organizations/Sponsors
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01374425
ClinicalTrials.gov processed this data on May 27, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.