Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborators: Amgen; Onyx Pharmaceuticals
• Treatments: Fluorouracil; Leucovorin; Levoleucovorin; Niacinamide; Oxaliplatin; Sorafenib

Criteria

Inclusion Criteria:

• Histological confirmation of adenocarcinoma of the colon or rectum

• Tumor tissue sample available for KRAS and BRAF assessment

• Measurable metastatic Stage IV disease including at least one measurable lesion that has not previously been radiated

• No prior chemotherapy for metastatic CRC

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

• Life expectancy of at least 12 weeks

• Adequate bone marrow, liver, and renal function; adequate clotting parameters

Exclusion Criteria:

• Prior treatment with sorafenib

• Clinical or radiographic evidence of brain metastasis

• Major surgery, surgical biopsy, or significant traumatic injury within 28 days of randomization; evidence or history of bleeding diathesis or coagulopathy

• Red blood cell (RBC), white blood cell (WBC), or platelet transfusions and/or growth factor use within 28 days before randomization

• Adjuvant therapy for CRC (Stage I, II, or III) completed within 12 months before randomization

• Serious, non-healing wound, ulcer, or bone fracture; Grade 3 or 4 hemorrhage within 28 days before randomization

• Use of anticoagulation therapy (low dose anticoagulation therapy to mitigate risk of thrombosis due to placement of a semi-permanent central venous port for administration of chemotherapy is allowed. The use of coumadin and related compounds is excluded.)

• Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg on repeated measurement) despite optimal medical management

• Thrombolic, embolic, venous, or arterial events (eg, cerebrovascular accident, including transient ischemic attacks) within 6 months before randomization

• Active cardiac disease including:

• Congestive heart failure

• Unstable angina or myocardial infarction within the 6 months before randomization

• Cardiac ventricular arrhythmias requiring antiarrhythmic treatment

• Peripheral neuropathy > Grade 1 (CTCAE)

• Known HIV infection or chronic hepatitis B or C infection

• Any active infection >/= Grade 2 (CTCAE)

• Any medical, psychological, or social condition that may interfere with the subject's participation in the study or evaluation of the study results

• Use of any investigational drug within 28 days or 5 half-lives of that drug, whichever is longer, before randomization

• Subjects with metastatic CRC who are currently candidates for surgery with curative intent