s-3304 in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: 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.

Eligibility criteria:
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

Keywords: unspecified adult solid tumor, protocol specific