Expired Study
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New York, New York 10065


Purpose:

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


Study summary:

OBJECTIVES: I. Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) administered with docetaxel in patients with progressive metastatic prostate cancer or other progressive metastatic or unresectable solid tumors. II. Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Patients are assigned to 1 of 2 treatment groups. Group 1: Patients receive docetaxel IV over 1 hour and 17-AAG IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Group 2: Patients receive docetaxel IV over 30 minutes and 17-AAG as in group 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients per group 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. Up to 20 additional patients (10 per group) are treated at the MTD. Patients are followed every 2-3 months.


Criteria:

Inclusion Criteria: - Histologically confirmed metastatic or unresectable malignancy for which standard curative or palliative therapy does not exist or is no longer effective - Progressive disease manifested by the following parameters - For prostate cancer: - Must have castrate, metastatic disease defined by disease progression after surgical castration or treatment with a gonadotropin-releasing hormone (GnRH) analog (testosterone level less than 50 ng/mL) - Patients who have not undergone surgical orchiectomy should continue on medical therapies to maintain castrate levels of testosterone - Progressive metastatic disease on imaging studies (bone scan, CT scan, or MRI) OR metastatic disease and a rising prostate-specific antigen (PSA) - Biochemical progression indicated by at least 3 rising PSA values (obtained at least 1 week apart) from a baseline OR 2 rising PSA values (more than 1 month apart), where the percentage increase over the range of values is at least 25% - Patients who have received an antiandrogen as part of first-line hormonal therapy must have shown progression of disease off of the antiandrogen prior to study enrollment - For other solid tumors: - Development of new lesions or an increase in pre-existing lesions by bone scintigraphy, CT scan, MRI, positron emission tomography, or physical examination - Patients whose sole criterion for progression is an increase in a biochemical marker (e.g., carcinoembryonic antigen or CA 15-3) or an increase in symptoms are not eligible - Patients with metastatic disease must not be progressing to the extent as to require palliative treatment within 4 weeks of study entry - No active brain metastases - Performance status - Karnofsky 70-100% - More than 6 months - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT < 1.5 times ULN - PT ≤ 1.1 times ULN - Creatinine no greater than 1.4 mg/dL or within ULN - Creatinine clearance greater than 55 mL/min - No prior history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine) - No dyspnea ≥ grade 2 at rest on room air - No requirement for supplementary oxygen therapy or oxygen saturations ≤ 88% - No clinically significant pulmonary comorbidities that require medication (e.g., severe chronic obstructive pulmonary disease that could predispose patient to pulmonary toxicity) - QTc ≤ 450 msec for male patients (470 for female patients) - LVEF > 40% by echocardiogram or MUGA - Echocardiogram or MUGA required for patients with any of the following: - Myocardial infarction > 1 year ago - NYHA class I or II CHF - Atrial fibrillation - Right or left bundle branch block by EKG - 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 active ischemic heart disease within the past year - No New York Heart Association (NYHA) class III or IV congestive heart failure (CHF) - No poorly controlled angina - No uncontrolled dysrhythmia - No congenital long QT syndrome - No left bundle branch block - No other significant cardiac disease - No prior history of cardiac toxicity after receiving anthracyclines such as doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No history of severe hypersensitivity reaction to paclitaxel, docetaxel, or polysorbate 80 - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No grade 2 or greater symptomatic peripheral neuropathy - No allergy to eggs or egg products - No other concurrent uncontrolled illness - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy to sole measurable lesion - No prior mantle-field radiotherapy - See Disease Characteristics - No concurrent surgery for sole measurable lesion - Recovered from prior therapy - At least 1 week since prior ketoconazole and recovered - At least 4 weeks since prior investigational anticancer therapeutic drugs - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent medications that prolong QTc interval - No concurrent medication used to control arrhythmias - Calcium blockers and beta blockers allowed - No other concurrent investigational agents - No other concurrent anticancer agents or therapies (investigational or commercial) - No concurrent CYP3A4 inhibitors, including any of the following: - Fluconazole - Itraconazole - Ketoconazole - Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or troleandomycin) - Nifedipine - Verapamil - Diltiazem - Cyclosporine - Grapefruit juice - No concurrent CYP3A4 inducers, including any of the following: - Carbamazepine - Phenobarbital - Phenytoin - Rifampin - No concurrent herbal extracts or tinctures with CYP3A4 inhibitory activity, including any of the following: - Hydrastis canadensis (goldenseal) - Hypericum perforatum (St. John's wort) - Uncaria tomentosa (cat's claw) - Echinacea angustifolia roots - Trifolium pratense (wild cherry) - Matricaria chamomilla (chamomile) - Glycyrrhiza glabra (licorice) - Dillapiol - Hypericin - Naringenin - Concurrent CYP3A4 substrates allowed


NCT ID:

NCT00058253


Primary Contact:

Principal Investigator
David Solit
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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