S-3304 in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have solid tumors.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose and safety profile of S-3304 in patients with advanced solid tumors. Determine the pharmacokinetic profile of this drug in these patients. Estimate the starting dose of this drug for subsequent phase II efficacy studies. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral S-3304 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 6-8 patients receive escalating doses of S-3304 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose-limiting toxicity. Patients are followed at 30 days. PROJECTED ACCRUAL: A total of 6-28 patients will be accrued for this study within 1 year.

Official Title
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A Phase I Study of S-3304 in Patients With Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: S-3304


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed solid tumor that failed to respond or relapsed after prior therapy or for which no standard therapy exists Biopsy-accessible lesion No brain metastasis unless clinically stable and off therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 6 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) Transaminases less than 2.5 times ULN Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 30 days after study Able to tolerate oral medication HIV negative No AIDS No serious underlying gastrointestinal disorders (e.g., recurrent vomiting or inflammatory bowel disease) No other serious concurrent illness PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Concurrent stable doses of epoetin alfa are allowed during the second and subsequent courses No other concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy Concurrent stable doses of steroids for prostate cancer are allowed during the second and subsequent courses No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: No prior significant gastric resection Other: Recovered from prior therapy At least 4 weeks since other prior investigational antitumor drugs No other concurrent investigational antitumor drugs Concurrent stable doses of bisphosphonates, cyclo-oxygenase-2 inhibitors, and non-steroidal anti-inflammatory drugs are allowed during the second and subsequent study courses

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: S-3304|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