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

Colorectal Cancer Clinical Trial

Official title:

Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00019773
• Other study ID #: CDR0000067201
• Secondary ID: NCI-99-C-0117MB-
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2001
• Last updated: April 28, 2015
• Start date: July 1999

Study information

• Verified date: April 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine the maximum tolerated dose (MTD) of capecitabine when administered with oxaliplatin in patients with colorectal, appendiceal, or small bowel cancer.

• Determine the clinical toxic effects associated with this regimen in these patients.

• Characterize the molecular profile of tumor tissue obtained prior to study entry for determinants of sensitivity to this regimen in this patient population.

• Characterize the molecular profile of a surrogate normal tissue (bone marrow aspirate) obtained prior to treatment and assess any potential drug-associated induction of DNA damage and inhibition of thymidylate synthase with a repeat bone marrow aspirate during therapy.

• Assess any clinical activity of this regimen in this patient population.

OUTLINE: This is a dose-escalation study of capecitabine.

Patients receive oxaliplatin IV over 2 hours on day 1 followed by oral capecitabine twice daily on days 1-5 and 8-12. Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 6 months.

PROJECTED ACCRUAL: A total of 106 patients will be accrued for this study within 36 months.

Other known NCT identifiers

• NCT00001817

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendiceal Neoplasms
• Carcinoma of the Appendix
• Colorectal Cancer
• Small Intestine Cancer

Intervention

Drug:
• capecitabine

• oxaliplatin

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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.

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.

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. — View Citation