Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin when given together with paclitaxel in treating patients with metastatic or unresectable solid tumor. Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining 17-N-allylamino-17-demethoxygeldanamycin with paclitaxel may kill more tumor cells


Study summary:

OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when administered with paclitaxel in patients with metastatic or unresectable solid malignancy. II. Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine tumor response in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Patients receive 17-AAG IV over 1 hour on days 1*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. NOTE: *17-AAG is not administered on day 1 of course 1. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6-12 patients are treated at the recommended phase II dose.


Criteria:

Inclusion Criteria: - Histologically confirmed solid malignancy - Metastatic or unresectable disease - Not amenable to standard curative or palliative therapy - No known brain metastases - Performance status - ECOG 0-2 - More than 12 weeks - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - WBC ≥ 3,000/mm^3 - AST and ALT ≤ 2.5 times upper limit of normal - Bilirubin normal - Creatinine normal - Creatinine clearance ≥ 60 mL/min - QTc < 450 msec for male patients (470 msec for female patients) - LVEF > 40% by MUGA - No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) - No myocardial infarction within the past year - No New York Heart Association class III or IV congestive heart failure - No poorly controlled angina - No history of uncontrolled dysrhythmia or requirement for antiarrhythmic drugs - No history of congenital long QT syndrome - No active ischemic heart disease within the past year - No left bundle branch block - No other significant cardiac disease - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double barrier contraception for at least 1 week before, during, and for at least 2 weeks after study participation - No prior allergy to eggs - No prior allergic reaction to compounds of similar chemical or biologic composition to 17-AAG or paclitaxel - No peripheral neuropathy > grade 1 - No concurrent uncontrolled illness - No active or ongoing infection - No psychiatric illness or social situation that would preclude study compliance - No concurrent granulocyte colony-stimulating factors - Prior paclitaxel allowed - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) - More than 4 weeks since prior radiotherapy - No prior radiotherapy that included the heart in the field (e.g., mantle radiotherapy) - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent therapeutic-dose warfarin for anticoagulation - No concurrent medications that may prolong QTc interval - No other concurrent investigational agents - No other concurrent anticancer agents or therapies


NCT ID:

NCT00087217


Primary Contact:

Principal Investigator
Suresh Ramalingam
University of Pennsylvania Medical Center


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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