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

Phase 1
18 Years
Not Enrolling
Carcinoma of the Appendix, Colorectal Cancer, Small Intestine Cancer

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Trial Information

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


- 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

- 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


- Histologically confirmed colorectal, appendiceal, or small bowel cancer

- Measurable disease

- No progression after prior capecitabine

- No brain metastases or leptomeningeal carcinomatosis



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin normal

- AST/ALT no greater than 2.5 times upper limit of normal


- Creatinine normal

- Creatinine clearance greater than 60 mL/min


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- 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


Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered


- 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


- 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


- Recovered from prior surgery


- 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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Eva Szabo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




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



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182