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

Primary Purpose

Carcinoma of the Appendix, Colorectal Cancer, Small Intestine Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
capecitabine
oxaliplatin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma of the Appendix focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
April 28, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019773
Brief Title
Oxaliplatin Plus Capecitabine in Treating Patients With Colorectal, Appendix, or Small Bowel Cancer
Official Title
Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2003
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
oxaliplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Szabo, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14981738
Citation
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.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
11919233
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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

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