Oxaliplatin Plus Capecitabine in Treating Patients With Colorectal, Appendix, or Small Bowel Cancer

NCT00019773 | Completed Phase 1

• 4 other identifiers: CDR0000067201NCI-99-C-0117MB-NAVY-99-01NCI-T99-0011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Carcinoma of the Appendix; Colorectal Cancer; Small Intestine Cancer

Keywords

stage I colon cancer; stage II colon cancer; stage III colon cancer; stage IV colon cancer; stage 0 colon cancer; stage 0 rectal cancer; stage I rectal cancer; stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; small intestine adenocarcinoma; small intestine lymphoma; small intestine leiomyosarcoma; recurrent small intestine cancer; carcinoma of the appendix

Interventions

capecitabine DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (4)

• Lehky 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 RESULT

• Leonard 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.

  RESULT

• Wilson 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 RESULT

• Thomas 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.

  RESULT

MeSH Terms

Conditions

Appendiceal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases; Colonic Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Eva Szabo, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 1999
• Last Updated: April 29, 2015

Record last verified: 2003-04

Locations

US (1)