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A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer



- 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.


- 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.

Inclusion Criteria


- Histologically confirmed prostate cancer

- Metastatic disease, as demonstrated by bone scan and/or CT scan of the

- Must demonstrate disease progression after initial hormone therapy (including
bicalutamide and flutamide)

- No prior chemotherapy allowed

- No known brain metastases


- 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate

Outcome Time Frame:

Treatment start date to date of best of response

Safety Issue:


Principal Investigator

Mark Stein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

April 2012

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Overlook Hospital Summit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown, New Jersey  07962
Cancer Institute of New Jersey at Hamilton Hamilton, New Jersey  08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Mountainside Hospital Montclair, New Jersey  07042