Expired Study
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Buffalo, New York 14263


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Patrick J. Creaven, MBBS, PhD
Roswell Park Cancer Institute

Backup Contact:


Location Contact:

Buffalo, New York 14263
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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