Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	Over 18	NCI	CINJ-080805 080805, 0220080244, NCT00786682

Objectives

Primary

1. 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

1. To measure time to disease progression and overall survival.
2. To determine the feasibility and safety of this regimen in these patients.

Entry 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

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

Patient Characteristics:

• ECOG performance status 0-1
• Life expectancy ≥ 6 months
• ANC > 1,500/μL
• Hemoglobin > 10 g/dL
• Platelet count > 100,000/mm³
• 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

Expected Enrollment

Outcomes

Tumor response rate
50% decline or normalization of PSA levels

Time to disease progression and overall survival
Feasibility and safety

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.

Trial Contact Information

Trial Lead Organizations

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Robert DiPaola, MD, Principal investigator		Ph: 732-235-7414

U.S.A.
New Jersey
	Hamilton
	Cancer Institute of New Jersey at Hamilton
		Clinical Trials Office - Cancer Institute of New Jersey at Hamilton	Ph:  609-631-6946
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Contact Person	Ph:  973-971-6100 800-247-9580
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Clinical Trials Office - Cancer Institute of New Jersey	Ph:  732-235-8675
	Summit
	Overlook Hospital
		Contact Person	Ph:  908-522-2000

Registry Information
Official Title		A Phase II Study of Docetaxel and Modulation of Autophagy with Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer
Trial Start Date		2008-12-23
Trial Completion Date		2011-10-01 (estimated)
Registered in ClinicalTrials.gov		NCT00786682
Date Submitted to PDQ		2008-10-21
Information Last Verified		2009-04-11
NCI Grant/Contract Number		CA72720

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