Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: docetaxel; hydroxychloroquine
Intervention MeSH terms: Hydroxychloroquine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV prostate cancer; recurrent 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.
    

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