Intermittent Chemotherapy With or Without GM-CSF for Metastatic HPRC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00488982
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : October 27, 2016
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This is a two-arm, randomized Phase II study of intermittent chemotherapy with and without GM-CSF. All patients will receive six 21-day cycles of docetaxel 75 mg/m2 on Day 2 of each cycle and 5 mg prednisone twice a day on Days 1-21. Following six cycles of chemotherapy, eligible subjects will be randomized to no maintenance therapy or to maintenance GM-CSF therapy. The GM-CSF group dose schedule will be 250 mcg/m2 SQ daily Days 15-28 every 28 days. Patients in both groups will continue until disease progression at which time GM-CSF will be discontinued and chemotherapy will again be administered.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel Drug: Docetaxel and GM-CSF Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Intermittent Chemotherapy or Intermittent Chemotherapy With Maintenance GM-CSF in Patients With Previously Untreated Hormone Refractory Prostate Cancer
Study Start Date : April 2007
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: 1
Drug: Docetaxel
Docetaxel 75mg/m2 every 21 days

Experimental: 2
Docetaxel and GM-CSF
Drug: Docetaxel and GM-CSF
Docetaxel 75mg/m2 every 21 days and GM-CSF 250mcg/m2 SQ days 15-28

Primary Outcome Measures :
  1. The primary objective is to determine time to progression while receiving chemotherapy (i.e., time to chemotherapy resistance) for both arms (intermittent docetaxel/prednisone with or without maintenance GM-CSF) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 1)Time to disease progression 2)Median overall survival 3)PSA response proportion 4)Cumulative time on and off chemotherapy 5)Toxicities [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age over 18 years
  2. Histologically documented adenocarcinoma of the prostate
  3. Progressive metastatic prostate cancer
  4. Castrate levels of testosterone (<50 ng/ml) must be maintained
  5. Prior hormonal therapy or medications :

    Patients who are receiving an anti-androgen, secondary hormonal therapy (i.e. ketoconazole, aminoglutethimide, megestrol acetate, diethylstilbestrol), 5-alpha reductase inhibitor (i.e. finasteride (Proscar), dutasteride (Avodart)) or herbal prostate medication (i.e. saw palmetto, PC-SPES, PC-PLUS) must discontinue the drug by the date of initiation of chemotherapy on study

  6. ≥ 4 weeks since major surgery and fully recovered
  7. ≥ 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to ≤grade 1
  8. ≥ 8 weeks since the last dose of strontium or samarium
  9. Sexually active patients must agree to use adequate contraception
  10. Karnofsky Performance Status ≥ 60%
  11. Life expectancy >12 weeks
  12. Required initial laboratory values Absolute neutrophil count > 1500/ul Platelets > 100,000/ul Hemoglobin > 8.0 g/dl Creatinine ≤ 2.0 X upper limit of normal Bilirubin ≤upper limit of normal (ULN)

AST/ALT/alkaline phosphatase:

AST AND ALT AND alkaline phosphatase must be within the range allowing for eligibility In determining eligibility, the more abnormal of the 2 values (AST or ALT should be used. An abnormal alkaline phosphatase must be attributed to liver dysfunction and not metastatic bone involvement (i.e elevated GGTP or evidence of liver metastases)

Inclusion criteria for late enrolling patients:

  1. Age over 18 years
  2. Histologically documented adenocarcinoma of the prostate
  3. ≤3 cycles of prior docetaxel chemotherapy for metastatic disease permitted prior to enrollment
  4. Docetaxel must have been administered on an every 3 week schedule
  5. Each docetaxel dose must have been between 60 and 75 mg/m2
  6. Castrate levels of testosterone <50 ng/mL
  7. Daily use of other steroids (hydrocortisone, dexamethasone) instead of prednisone or no steroids, is permitted up until time of enrollment
  8. A PSA level must have been documented within 6 weeks of initiating docetaxel chemotherapy

Exclusion Criteria:

  1. Prior systemic chemotherapy for prostate cancer, other than q 3-week docetaxel/prednisone. Prior neoadjuvant or adjuvant chemotherapy is permitted if there was no evidence of disease relapse within 12 months of the last dose of chemotherapy.
  2. >3 cycles of q3 week docetaxel/prednisone chemotherapy has already been administered to the patient
  3. Peripheral neuropathy >grade 1
  4. Prior immunotherapy including systemic GM-CSF or vaccines utilizing GM-CSF; prior G-CSF support of chemotherapy-related neutropenia is permitted
  5. Prior biologic agents (i.e.,anti-angiogenic agents, anti-EGFR inhibitors)≤ 4 weeks prior to registration
  6. More than two prior therapies with an investigational agent, completed ≤ 4 weeks prior to enrollment (no prior immunotherapeutics are allowed)
  7. Myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia
  8. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded
  9. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 will be excluded
  10. Poorly controlled diabetes (fasting blood glucose >250) despite optimization of medical therapy

Exclusion criteria for late enrolling patients:

  1. Prior immunotherapy including systemic GM-CSF or vaccines utilizing GM-CSF; prior G-CSF support for chemotherapy-related neutropenia is permitted
  2. Delay of ≥6 weeks between any 2 chemotherapy cycles prior to enrollment on study
  3. Cumulative delays ≥8 weeks between chemotherapy cycles prior to enrollment on study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00488982

United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States
United States, Oregon
Oregon Health and Science University Cancer Institute
Portland, Oregon, United States, 97239
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of California, San Francisco
Genzyme, a Sanofi Company
Principal Investigator: Eric Small, MD University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT00488982     History of Changes
Other Study ID Numbers: UCSF055511
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by University of California, San Francisco:
Metastatic Hormone Refractory Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action