Prostate Cancer Clinical Trial
Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer
Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help docetaxel work better and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with hydroxychloroquine works in treating patients with metastatic prostate cancer.
Full Description
OBJECTIVES:
Primary
To assess the antitumor activity, in terms of tumor response rate, of docetaxel in combination with hydroxychloroquine in patients with metastatic, hormone-refractory, chemotherapy-naive prostate cancer.
Secondary
To measure time to disease progression and overall survival.
To determine the feasibility and safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral hydroxychloroquine twice daily on days 1-21 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days (up to 6 courses with docetaxel) in the absence of disease progression or unacceptable toxicity.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Metastatic disease, as demonstrated by bone scan and/or CT scan of the abdomen/pelvis
Must demonstrate disease progression after initial hormone therapy (including bicalutamide and flutamide)
No prior chemotherapy allowed
No known brain metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Life expectancy ≥ 6 months
ANC > 1,500/μL
Hemoglobin > 10 g/dL
Platelet count > 100,000/mm^3
Serum creatinine < 2.0 mg/dL or creatinine clearance > 50 mL/min
Total bilirubin normal
SGOT and/or SGPT < 1.5 times upper limit of normal (ULN)
Alkaline phosphatase < 2.5 times ULN
Fertile patients must use effective contraception during and for 3 months after completion of study therapy
No second primary malignancy except for most in situ carcinomas (e.g., adequately treated nonmelanoma carcinoma of the skin) or other malignancy treated ≥ 5 years ago with no evidence of recurrence
No history or symptoms of cardiovascular disease, including any of the following:
NYHA class II-IV cardiovacular disease within the past 6 months
Coronary artery disease
Arrhythmias
Conduction defects with risk of cardiovascular instability
Uncontrolled hypertension
Clinically significant pericardial effusion
Congestive heart failure
No uncontrolled intercurrent illness including ongoing active infection that would limit compliance with study requirements
No rheumatoid arthritis or systemic lupus erythematosus requiring treatment
No psoriasis or porphyria
No known HIV infection
No hypersensitivity to 4-aminoquinoline compounds, including hydroxychloroquine sulfate, chloroquine phosphate, and amodiaquine
No retinal or vision changes from prior 4-aminoquinoline compound use
No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
No known G-6PDH deficiency
Neurotoxicity ≤ grade 1
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Recovered from all prior therapy
No prior taxane
At least 4 weeks since prior therapy (including surgery and radiotherapy)
At least 1 week since prior herbal supplements
At least 6 weeks since prior bicalutamide
At least 4 weeks since prior flutamide
No current hydroxychloroquine for treatment or prophylaxis
Prior hydroxychloroquine allowed
No other concurrent investigational or commercial agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, surgery for cancer, or experimental therapy
Concurrent luteinizing-hormone releasing-hormone agonists allowed
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There are 6 Locations for this study
Hamilton New Jersey, 08690, United States
Montclair New Jersey, 07042, United States
Morristown New Jersey, 07962, United States
New Brunswick New Jersey, 08903, United States
New Brunswick New Jersey, 08903, United States
Summit New Jersey, 07901, United States
Philadelphia Pennsylvania, 19111, United States
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