Clinical trial · Interventional
Oxaliplatin Plus Capecitabine in Treating Patients With Colorectal, Appendix, or Small Bowel Cancer
Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients
NCT00019773CI-TRIAL-00017683completedPhase 1ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have colorectal, appendix, or small bowel cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma of the Appendix | Appendix Carcinoma | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal, appendiceal, or small bowel cancer * Measurable disease * No progression after prior capecitabine * No brain metastases or leptomeningeal carcinomatosis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal Renal: * Creatinine normal * Creatinine clearance greater than 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No sensory neuropathy * No history of allergy to platinum compounds * No history of allergy to antiemetics appropriate for administration during study * No history of intolerance to fluorouracil * No uncontrolled concurrent illness that would preclude study entry * No ongoing or active infection requiring IV antibiotics * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered Chemotherapy: * See Disease Characteristics * Recovered from prior chemotherapy * No more than 2 prior systemic chemotherapy regimens for metastatic disease * At least 6 weeks since prior nitrosoureas or mitomycin * At least 8 weeks since prior eniluracil * At least 3 months since prior suramin * At least 4 weeks since other prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Recovered from prior radiotherapy * At least 2 weeks since prior radiotherapy to no more than 20% of bone marrow reserve * At least 4 weeks since prior radiotherapy to at least 21% of bone marrow reserve Surgery: * Recovered from prior surgery Other: * At least 4 weeks since prior sorivudine or brivudine and recovered * No concurrent sorivudine or brivudine * No other concurrent investigational agents * No other concurrent anticancer therapy or commercial agents
References
Publications (4)
- RESULTLehky TJ, Leonard GD, Wilson RH, Grem JL, Floeter MK. Oxaliplatin-induced neurotoxicity: acute hyperexcitability and chronic neuropathy. Muscle Nerve. 2004 Mar;29(3):387-92. doi: 10.1002/mus.10559. PMID 14981738
- RESULTLeonard G, Wright M, Quinn M, et al.: Survey of oxaliplatin-associated neurotoxicity with an interview-based questionnaire. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-3018, 2003.
- RESULTWilson RH, Lehky T, Thomas RR, Quinn MG, Floeter MK, Grem JL. Acute oxaliplatin-induced peripheral nerve hyperexcitability. J Clin Oncol. 2002 Apr 1;20(7):1767-74. doi: 10.1200/JCO.2002.07.056. PMID 11919233
- RESULTThomas R, Quinn M, Wilson R, et al.: A phase I trial of capecitabine (CAPE) & oxaliplatin (OHP). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-530, 2001.