combination chemotherapy in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of combining flavopiridol with docetaxel in treating patients who have advanced solid tumors.

objectives: * determine the maximum tolerated dose of flavopiridol when administered in combination with 2 different doses of docetaxel in patients with advanced solid tumors. * determine the clinical pharmacokinetics of this regimen in these patients. * determine, preliminarily, the therapeutic activity of this regimen in these patients. outline: this is a dose-escalation study of flavopiridol. patients receive docetaxel iv over 30 minutes followed at least 4 hours later by flavopiridol iv over 1 hour on days 1, 8, and 15. courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. separate mtds of flavopiridol are determined when flavopiridol is combined with 2 different doses of docetaxel. a total of 10 patients are treated at each flavopiridol mtd. patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. projected accrual: a total of 6-56 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists * measurable or evaluable disease * no symptomatic or untreated cns metastases or primary cns neoplasm patient characteristics: age * 18 and over performance status * karnofsky 70-100% life expectancy * not specified hematopoietic * wbc at least 3,500/mm3 * absolute neutrophil count at least 1,500/mm3 * platelet count at least 100,000/mm3 * hemoglobin at least 8 g/dl hepatic * bilirubin no greater than upper limit of normal (uln) * sgot/sgpt no greater than 2.5 times uln if alkaline phosphatase no greater than uln or * alkaline phosphatase no greater than 2.5 times uln if sgot/sgpt no greater than uln renal * creatinine no greater than 1.5 mg/dl cardiovascular * no history of cardiac arrhythmias * no congestive heart failure * no myocardial infarction within the past 6 months other * no concurrent serious or uncontrolled infection * no diabetes not adequately controlled with medication * no peripheral neuropathy greater than grade 1 * no known allergy to docetaxel or other medications formulated in polysorbate 80 * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 2 months after study prior concurrent therapy: biologic therapy * at least 4 weeks since prior immunotherapy chemotherapy * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * prior taxanes allowed * no prior flavopiridol endocrine therapy * at least 4 weeks since prior hormonal therapy radiotherapy * at least 4 weeks since prior radiotherapy surgery * not specified other * recovered from prior therapy * no prior enrollment in this study

Keywords: unspecified adult solid tumor, protocol specific