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Intermittent Chemotherapy With or Without Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Metastatic Hormone Refractory Prostate Cancer (HRPC)

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.
 
ClinicalTrials.gov Identifier: NCT00488982
Recruitment Status : Completed
First Posted : June 20, 2007
Results First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
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 subcutaneous (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

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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

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Docetaxel + Observation
Intermittent docetaxel/prednisone with no maintenance therapy: Patients will discontinue docetaxel/prednisone and undergo observation until disease progression at which time they will re-initiate docetaxel/prednisone. Six cycles of docetaxel/prednisone will again be administered before subsequent discontinuation of chemotherapy
Drug: Docetaxel
Docetaxel 75mg/m2 every 21 days

Experimental: Docetaxel + GM-CSF
Intermittent docetaxel/prednisone with maintenance GM-CSF therapy: Patients will discontinue docetaxel/prednisone and will receive maintenance GM-CSF until disease progression at which time, they will discontinue GM-CSF and resume docetaxel/prednisone. Six cycles of docetaxel/prednisone will again be administered before discontinuation of chemotherapy and GM-CSF therapy is re-initiated. GM-CSF dose/schedule will be as previously described (250 mcg/m2 SQ daily, days 15-28 q28 days)
Drug: Docetaxel and GM-CSF
Docetaxel 75mg/m2 every 21 days and GM-CSF 250mcg/m2 SQ days 15-28




Primary Outcome Measures :
  1. Time to Progression [ Time Frame: Up to 7 years ]
    The Kaplan-Meier product limit method with 95% confidence intervals will be used to estimate the median time to disease progression during initial course of randomized treatment


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 7 years ]
    The Kaplan-Meier product limit method will be used to estimate the median overall survival

  2. Number of Participants With PSA Response to Successive Series of Chemotherapy [ Time Frame: Up to 6 years ]
    PSA partial response is defined by at least a 50% decline from PSA value from the baseline measurement to 12 weeks of protocol therapy. The decline must be confirmed by a second PSA value obtained 4 or more weeks later For those patients whose PSA have decreased but has not reached response criteria defined above, progressive disease is defined as 25% increase over the nadir PSA value provided that the increase is at least 5ng/mL and is confirmed.

  3. Cumulative Duration of Time on and Off Docetaxel-based Therapy [ Time Frame: Up to 7 years ]
    Median percentage of time will be calculated to summarize the total duration of chemotherapy and amount of docetaxel/prednisone administered while the patient is on study. The same results will be tabulated for each. For the on-chemotherapy period: will be estimated from the date of starting protocol therapy; if a patient received docetaxel on day 2 of a cycle, he will be considered to have received a full 21 days on therapy. For the off-chemotherapy period: will be calculated from the date of starting the observation or GM-CSF period to the date of resuming chemotherapy



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

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)

aspartate aminotransferase (AST) / alanine aminotransferase (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 gamma-glutamyl transpeptidase (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 Prostate-specific antigen (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-Epithelial Growth Factor Receptor (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 ClinicalTrials.gov identifier (NCT number): NCT00488982


Locations
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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, 02215
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
Investigators
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Principal Investigator: Eric Small, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00488982    
Other Study ID Numbers: 055511
NCI-2011-01269 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: June 20, 2007    Key Record Dates
Results First Posted: November 20, 2019
Last Update Posted: November 20, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, San Francisco:
Metastatic Hormone Refractory Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Hormones
Sargramostim
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunologic Factors