S-3304 in Treating Patients With Advanced Solid Tumors

Roswell Park Cancer Institute

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

S-3304DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.