Clinical trial · Interventional
Sunitinib and Capecitabine for First Line Colon Cancer
A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unanticipated side effects and futility
Summary
Brief summary (as posted)
This study is for patients with metastatic colorectal cancer who have not been treated with chemotherapy for their cancer. The purpose of this study is to find out if Capecitabine and Sunitinib can be used together to improve progression-free survival in colorectal cancer. All patients will take two medicines (Sunitinib and Capecitabine) by mouth every day until their cancer gets worse.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib and capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sunitinib and cepecitabine
- description
- Administration of sunitinib and capecitabine
- interventionNames
- Drug: sunitinib and capecitabine
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- 36 months
- description
- Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, newly diagnosed metastatic colorectal cancer * Measurable or evaluable disease in which surgical resection with curative intent is not possible * No adjuvant chemotherapy within 6 months of enrollment * No prior sunitinib or other receptor tyrosine kinase inhibitors * 18 years of age or greater * Anticipated survival of at least 6 months * Ambulatory with an ECOG performance status of 0 or 1 and able to maintain weight * Normal organ and marrow function * Must agree to avoid pregnancy or fathering a child through out study participation * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * Chemotherapy or radiotherapy within 6 months of enrollment * Receiving any other investigational agents * Known untreated brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis * Not able to ingest oral medications with normal absorption from the GI tract * Uncontrolled hypertension * History of severe/unstable angina, heart attack, congestive heart failure, transient ischemic attack, or stroke within 6 months of enrollment * Cardiac dysrhythmias * History of clinically significant bleeding within the past 6 months, including gross hemoptysis or hematuria, or underlying coagulopathy * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study enrollment * Current treatment with therapeutic doses of coumadin * Concurrent malignancy other than colorectal cancer * Known dihydropyrimidine dehydrogenase deficiency * Uncontrolled intercurrent illness including ongoing or active infection or psychiatric illness that would limit compliance with study requirements. * Pregnant and nursing women
References
Publications (0)
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