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Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer
This study has been suspended.
( Pending amendment )

First Received on November 5, 2008.   Last Updated on October 12, 2011   History of Changes
Sponsor: University of Medicine and Dentistry New Jersey
Collaborator: National Cancer Institute (NCI)
Information provided by (Responsible Party): University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00786682
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: hydroxychloroquine
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Tumor response rate [ Time Frame: Treatment start date to date of best of response ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression and overall survival [ Time Frame: Treatment start date to time to progression and time to death ] [ Designated as safety issue: No ]
  • Feasibility and safety [ Time Frame: Treatment start date to 30 days after end of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: December 2008
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: docetaxel
    dose of 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
    Drug: hydroxychloroquine
    200 mg twice daily
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, 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786682

Locations
United States, New Jersey
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Mountainside Hospital
Montclair, New Jersey, United States, 07042
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Overlook Hospital
Summit, New Jersey, United States, 07901
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Mark Stein, MD Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00786682     History of Changes
Other Study ID Numbers: CDR0000617998, P30CA072720, CINJ-080805, 0220080244
Study First Received: November 5, 2008
Last Updated: October 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hydroxychloroquine
Docetaxel
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012