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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
Est. completion date
Est. primary completion date
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


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

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