Colon Cancer Clinical Trial

Suberoylanilide Hydroxamic Acid, Fluorouracil, Leucovorin, and Oxaliplatin in Treating Patients With Progressive Metastatic or Unresectable Colorectal Cancer or Other Solid Tumors

Summary

This phase I trial is studying the side effects and best dose of suberoylanilide hydroxamic acid when given together with fluorouracil, leucovorin, and oxaliplatin in treating patients with progressive metastatic or unresectable colorectal cancer or solid tumor. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

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Full Description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of suberoylanilide hydroxamic acid when administered with fluorouracil, leucovorin calcium, and oxaliplatin in patients with progressive metastatic or unresectable colorectal cancer or other solid tumors.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this regimen in these patients. II. Determine the pharmacokinetics of oxaliplatin, fluorouracil, and suberoylanilide hydroxamic acid in these patients.

OUTLINE: This is a dose-escalation study of suberoylanilide hydroxamic acid (SAHA).

Patients receive oral SAHA once or twice daily on days 1-3. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 4 followed by fluorouracil IV over 46 hours on days 4-5. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SAHA 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. A total of 10 patients are treated at the MTD.

After completion of study treatment, patients are followed for 4 weeks.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed colorectal cancer
Metastatic or unresectable disease OR diagnosis of solid tumor
No known brain metastases
ECOG 0-1 OR Karnofsky 70-100%
Life expectancy > 12 weeks
Absolute neutrophil count ≥ 1,500/mm^3
WBC ≥ 3,000/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin normal
AST and ALT ≤ 3 times upper limit of normal
Creatinine normal OR creatinine clearance ≥ 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 during and for 3 months after study participation
No ongoing or active infection
No neuropathy > grade 1
No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
No psychiatric illness or social situation that would preclude study compliance
No psychiatric illness or social situation that would preclude study compliance
No other uncontrolled illness
Prior bevacizumab and/or cetuximab allowed
No concurrent routine or prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
More than 4 weeks since prior radiotherapy
Recovered from prior therapy
At least 2 weeks since prior valproic acid
No concurrent combination anti-retroviral therapy for HIV-positive patients
No other concurrent investigational agents
No other concurrent anticancer therapy

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT00138177

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT00138177

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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