Spots Global Cancer Trial Database for Tanespimycin, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors

Study Description

Brief Summary: This phase I trial studies the side effects, best way to give, and best doses of tanespimycin with or without gemcitabine hydrochloride and cisplatin in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as tanespimycin, gemcitabine hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Using more than one drug (combination chemotherapy) may kill more tumor cells.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of 17-AAG (tanespimycin) when given on days 1 and 8 of every 3 weeks cycle in combination with Gemzar (gemcitabine hydrochloride) and CDDP (cisplatin) (cohorts A, B, and E). II. To determine the MTD of 17-AAG plus Gemzar when Gemzar is given on days 1 and 8 and 17-AAG is given on days 2 and 9 every 3 weeks (cohort C). III. To determine the MTD of 17-AAG plus CDDP when given on days 1 and 8 every 3 weeks (cohort D). IV. To define the dose-limiting toxicity of 17-AAG when used in combination with Gemzar and CDDP. V. To assess the effect of 17-AAG on surrogate markers when used in combination with Gemzar and CDDP. VI. To report any responses observed. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 3 treatment cohorts. Cohort A (closed to accrual as of 3/2/04)\*: Patients receive escalating doses of gemcitabine hydrochloride intravenously (IV) over 30 minutes, tanespimycin IV over 1 hour, and cisplatin IV over 2 hours on days 1 and 8. NOTE: \*The maximum tolerated dose (MTD) of this 3-drug combination has been determined as of 3/2/04. Cohort B (closed to accrual as of 3/2/05): Patients receive gemcitabine hydrochloride\*\* IV over 30 minutes, tanespimycin IV over 1 hour, and cisplatin\*\* IV over 2 hours on days 1 and 8. Cohort C: Patients receive gemcitabine hydrochloride\*\* IV over 30 minutes and tanespimycin IV over 1-2 hours on days 2 and 9. Cohort D: Patients receive cisplatin\*\* IV over 2 hours and tanespimycin IV over 1-2 hours on days 1 and 8. Cohort E: Patients receive gemcitabine hydrochloride\*\*\*, tanespimycin\*\*\*, and cisplatin\*\*\* as in cohort B. In all cohorts, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 months. NOTE: \*\*Gemcitabine hydrochloride and cisplatin dosage is constant, while 17-AAG is escalated in cohorts B, C, and D. NOTE: \*\*\*Gemcitabine hydrochloride dosage is constant, 17-AAG is started at a higher dose level than all other cohorts, and cisplatin dosage is escalated in cohort E.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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