Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients
18 Years
N/A
Both
Carcinoma of the Appendix, Colorectal Cancer, Small Intestine Cancer
Trial Information
Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Eva Szabo, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
CDR0000067201
NCT ID:
NCT00019773
Start Date:
July 1999
Completion Date:
Related Keywords:
- Carcinoma of the Appendix
- Colorectal Cancer
- Small Intestine Cancer
- 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
- Carcinoma
- Colorectal Neoplasms
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Intestinal Neoplasms
- Colonic Neoplasms
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
