Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer

NCT00786682 | Terminated Phase 2 Results

• 3 other identifiers: CDR0000617998P30CA072720CINJ-080805
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 7

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 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.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.

  We will use a two-stage optimal Simon's design with a 5% significance level and 80% power to detect an increase in response rate from 50% to 70%. The first stage will enroll 15 patients. If there are 8 or fewer responses among these 15 patients, we will consider the combination therapy to not be worthy of further study, and stop the trial. If we find 9 or more responses, we will proceed to the second stage, and accrual continues for a total of 43 patients. If we see 26 or fewer responses out of 43, then no further investigation of the drug is warranted. If we see 27 or more responses out of 43, then further investigation of the drug will be considered. The "expected" sample size of the trial is 23.5 with the null response rate of 50%.

  4 years

Secondary Outcomes (2)

• Time to Disease Progression

  10 years

• Overall Survival

  10 years

Study Arms (1)

Docetaxel and Hydroxychloroquine

EXPERIMENTAL

Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle Drug: hydroxychloroquine 200 mg twice daily A cycle is defined as an interval of 21 days.

Drug: docetaxel; Drug: hydroxychloroquine

Interventions

docetaxel DRUG

Docetaxel and Hydroxychloroquine

hydroxychloroquine DRUG

Docetaxel and Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Mountainside Hospital

Montclair, New Jersey, 07042, United States

Location

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

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

New Brunswick, New Jersey, 08903, United States

Location

St. Peters University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Overlook Hospital

Summit, New Jersey, 07901, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Mark Stein
• Organization: Cancer Institute of New Jersey

steinmn@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu

732-235-8675

Study Officials

• Mark Stein, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: December 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 14, 2023
• Results First Posted: November 25, 2013

Record last verified: 2023-07

Locations

US (7)