Clinical trial · Interventional
Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects
Phase 2b, DB, Randomized Study Evaluating Efficacy & Safety of Sorafenib Compared With Placebo When Administered in Combination With Modified FOLFOX6 for the Treatment of Metastatic CRC Subjects Previously Untreated for Stage IV Disease
NCT00865709CI-TRIAL-00016326completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin) | Drug | — | UNRESOLVED |
| Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
- description
- Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
- type
- PLACEBO_COMPARATOR
- label
- Matching placebo + mFOLFOX6
- description
- Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
- interventionNames
- Drug: Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTTabernero J, Garcia-Carbonero R, Cassidy J, Sobrero A, Van Cutsem E, Kohne CH, Tejpar S, Gladkov O, Davidenko I, Salazar R, Vladimirova L, Cheporov S, Burdaeva O, Rivera F, Samuel L, Bulavina I, Potter V, Chang YL, Lokker NA, O'Dwyer PJ. Sorafenib in combination with oxaliplatin, leucovorin, and fluorouracil (modified FOLFOX6) as first-line treatment of metastatic colorectal cancer: the RESPECT trial. Clin Cancer Res. 2013 May 1;19(9):2541-50. doi: 10.1158/1078-0432.CCR-13-0107. Epub 2013 Mar 26. PMID 23532888