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

Completed · Phase 2 · Has a placebo group

Conditions studied: Metastatic Colorectal Cancer

In brief

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

Key facts

Study ID

NCT00865709

Run by

Bayer

People needed

198

Starts

2009-03-01

Expected to finish

2012-02-01

Last updated by the study team

2014-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Metairie, Louisiana, United States
• Study site — Brockton, Massachusetts, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Dallas, Texas, United States
• Study site — Antwerp, Belgium
• Study site — Bruxelles - Brussel, Belgium
• Study site — Bruxelles - Brussel, Belgium
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Liège, Belgium
• Study site — Budapest, Hungary
• Study site — Budapest, Hungary
• Study site — Budapest, Hungary
• Study site — Debrecen, Hungary
• Study site — Győr, Hungary
• Study site — Kecskemét, Hungary
• Study site — Szeged, Hungary
• Study site — Székesfehérvár, Hungary
• Study site — Castelfranco Veneto, Treviso, Italy
• Study site — Genova, Italy
• Study site — Palermo, Italy
• Study site — Pordenone, Italy
• Study site — Province of Macerata, Italy
• Study site — Torino, Italy
• Study site — Wichita, Kansas, United States

Full record on ClinicalTrials.gov

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