A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Hedgehog, CRC, Colorectal Cancer, Hedgehog Pathway Inhibitor
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Histologically confirmed metastatic colorectal cancer (CRC)
- Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, must be confirmed to be available and requested at any time prior to entry of study
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematopoetic capacity
- Adequate hepatic function
- Adequate renal function
- Use of an effective method of barrier contraception (for women of childbearing potential)
- Signed informed consent
Exclusion Criteria:
- Prior chemotherapy for metastatic CRC or adjuvant chemotherapy for CRC within the prior 6 months
- Clinically suspected or confirmed CNS metastases or carcinomatous meningitis
- Major surgical procedure within 4 weeks prior to the first day of treatment in this study (Day 1)
- Pelvic radiation within 2 weeks prior to Day 1
- Wound dehiscence requiring intervention, gastrointestinal perforation, or bowel obstruction
- Pregnancy or lactation
- Uncontrolled medical illnesses including the following: Infection requiring intravenous (IV) antibiotics, congestive heart failure not controlled with medication, hypertension not controlled with medication
- Thromboembolic disease
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Vismodegib 150 mg
Placebo to vismodegib
Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.