Clinical trial · Interventional
Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer
Phase II Trial of OSI-774 (Erlotinib, Tarceva™,) and Capecitabine for Patients With Previously Untreated 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): Study halted by drug manufacturer
Summary
Brief summary (as posted)
To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer. Time to tumor progression, objective response rate, time to confirmed response rate, duration of confirmed response rate, time to treatment failure, and CEA response will be assessed.
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 |
|---|---|---|---|
| Erlotinib and capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer
- timeFrame
- Time to tumor progression, time to confirmed response rate, time to treatment failure, .
Secondary outcomes (1)
- measure
- To determine the qualitative and quantitative toxicity of this combination and sequence of drug administration
- timeFrame
- Objective response rate, duration of confirmed response rate, CEA response will be assessed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have histologically or cytologically confirmed diagnosis of metastatic colorectal adenocarcinoma. * Patients must be \> 18 years old. * Patients must have a performance status of \> 60 on the Karnofsky scale * Patients must have an expected life expectancy of at least 12 weeks. * Patients must give written informed consent as per institutional and federal regulatory requirements. * Patients must have measurable or evaluable disease . * Patients must have an absolute neutrophil count of \> 1,500/mm3 and a platelet count \> 100,000/mm3. * Patients must have adequate liver and renal function defined by a bilirubin of \< 2.0 mg/dl and a creatinine of \< 1.5 mg/dl, respectively. * Patients must be able to stay in the general area for the duration of their treatment on this clinical research study. Exclusion Criteria: * Prior chemotherapy, treatment with inhibitors of EGFR of any kind, molecularly targeted * Pregnant or lactating women * Clinical signs of brain involvement or leptomeningeal disease * Serious illness or medical conditions * Congestive heart failure or unstable angina pectoris, uncontrolled hypertension or arrhythmias * Active infections * UnstaOphthalmic disorders that might increase the risk for epithelium related complications (bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis e.g.) * GI tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g. Crohn's disease, ulcerative colitis) or post surgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and vitamin deficiency orequires IV hyperalimentation (however, use of pancreatic enzyme supplementation is allowed provided that the above criteria are not met). * Prior invasive malignancies for less 5 years * Known to be HIV positive.
References
Publications (1)
- BACKGROUNDVan Halteren HK, Roumen RM, Coebergh JW, Croiset van Uchelen FA, Keuning JJ, Vreugdenhil G. The impact of 5-FU-based bolus chemotherapy on survival in patients with advanced colorectal cancer. Anticancer Res. 1999 Jul-Aug;19(4C):3447-9. PMID 10629633