Clinical trial · Interventional
Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer
NCT01471353CI-TRIAL-00046121SorCapecompletedPhase 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)
Combining Sorafenib with standard cytotoxic fluoropyrimidine therapy for advanced colorectal cancer may provide clinical benefit when no other treatment remains.
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 |
|---|---|---|---|
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib Plus Capecitabine (SorCape) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib Plus Capecitabine (SorCape)
- description
- Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
- interventionNames
- Drug: Sorafenib Plus Capecitabine (SorCape)
Primary outcomes (1)
- measure
- Sorafenib Activity
- timeFrame
- 2 years
- description
- Determine activity of sorafenib plus capecitabine on progression free survival (PFS) in patients with advanced colorectal cancer. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven adenocarcinoma of the colon or rectum. * Metastatic disease that is not amenable to potentially curative treatment. * Measurable disease (as per RECIST 1.1 criteria). * At least one prior chemotherapeutic regimen for metastatic disease. Patients must have progressed following oxaliplatin based therapy (in either the adjuvant or metastatic setting) and irinotecan based therapy (in the metastatic setting). * Adequate bone marrow, liver and renal function. * Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate, provided stability in anticoagulation therapy is documented at the treating provider's discretion. For patients on warfarin, the INR should be measured prior to the initiation of study treatment and should be monitored at least weekly, or as defined by the local standard of care, until INR is stable. * Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. * Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib. * Patients may have had a history of other (non-colorectal) malignancies if there is no current evidence of persistent or recurrent disease and they are not undergoing any active therapy (including hormonal). * Patients should have paraffin-embedded tissue from initial diagnosis or prior colorectal cancer surgery available for molecular analysis. * Patients must consent to participate in the study and must have signed and dated an IRB-approved consent form conforming to federal and institutional guidelines. Consent must be obtained prior to any study specific procedures. Exclusion Criteria: * Prior therapy with a tyrosine kinase inhibitor. * Age \< 18 years * ECOG Performance Status \> 2 * Less than 28 days elapsed from prior radiation therapy, surgery or chemotherapy to the time of registration. * History of known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis. * History of clinically significant cardiac disease (severe/unstable angina pectoris, NYHA class III or IV congestive heart failure, symptomatic coronary artery disease) or myocardial infarction, cerebrovascular accident or transient ischemic attack within the last 12 months. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Uncontrolled hypertension defined as systolic blood pressure \> 140 mmHg or diastolic pressure \> 90 mmHg, as measured on 3 consecutive pre-enrollment assessments, despite optimal medical management. * Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C. * Active clinically serious infection \> CTCAE Grade 2. * Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug. * Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug. * Pulmonary embolism or any other uncontrolled thromboembolic event within 3 months prior to registration or occurrence of deep vein thrombosis within 4 weeks of registration. * Serious non-healing wound, ulcer, or bone fracture. * Evidence or history of a clinically significant bleeding diathesis or coagulopathy (without vitamin K antagonist therapy). * Use of St. John's Wort or rifampin (rifampicin). * Known or suspected allergy to sorafenib or capecitabine. * Any condition that impairs patient's ability to swallow whole pills. * Any known malabsorption problem. * History of chronic or inflammatory bowel disorders, clinically significant chronic diarrhea refractory to medical management, or unresolved bowel obstruction.
References
Publications (0)
Data not yet available
No reference posted for this study.