Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors.

Detailed Description
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OBJECTIVES: Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors. Determine the toxic effects of this regimen in these patients. Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients. Assess, in a preliminary manner, the antitumor activity of this regimen in these patients. OUTLINE: This is a dose de-escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.

Official Title
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5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: fluorouracil
* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value Must have disease that can be safely and readily biopsied under local anesthesia (including, but not limited to, subcutaneous metastases, superficial lymph node metastases, or ascites) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST less than 2 times ULN Alkaline phosphatase less than 2 times ULN Lactic dehydrogenase less than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: HIV negative No active uncontrolled bacterial, viral, or fungal infection No nonmalignant systemic disease that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No prior irinotecan Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy except small-port radiotherapy for local control No concurrent radiotherapy except small-port radiotherapy for local disease control (e.g., pain relief or impending fracture) Surgery: See Disease Characteristics At least 2 weeks since prior major surgery Other: No concurrent anticoagulants except warfarin or subcutaneous heparin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluorouracil|nan|
|Drug: irinotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific