Status:
TERMINATED
Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE2
Brief 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 ma...
Detailed 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, chemothe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00786682
Start Date
December 1 2008
End Date
October 1 2012
Last Update
August 14 2023
Active Locations (7)
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1
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
2
Mountainside Hospital
Montclair, New Jersey, United States, 07042
3
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
4
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903