S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00028769 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Results First Posted : July 16, 2013
Last Update Posted : July 16, 2013
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Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
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Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: bicalutamide Drug: estramustine Drug: etoposide Drug: flutamide Drug: goserelin Drug: leuprolide Drug: nilutamide Drug: paclitaxel | Phase 2 |
OBJECTIVES:
- Determine the progression-free and overall survival in patients with high-risk metastatic adenocarcinoma of the prostate treated with early estramustine, etoposide, and paclitaxel with combined androgen-blockade therapy.
- Determine the type, frequency, and severity of toxicity of this regimen in this patient population.
OUTLINE: This is a multicenter study.
- Androgen-blockade therapy: Patients receive a standard regimen of luteinizing hormone-releasing hormone agonist therapy comprising either goserelin subcutaneously once monthly or once every 3 months or leuprolide intramuscularly once monthly, once every 3 months, or once every 4 months. Patients also receive a standard regimen of antiandrogen therapy comprising oral bicalutamide, oral flutamide, or oral nilutamide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Chemotherapy: Beginning 14-30 days after initiation of androgen-blockade therapy, patients receive oral estramustine three times daily and oral etoposide once daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression, every 6 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 2 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 41 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate |
| Study Start Date : | December 2001 |
| Actual Primary Completion Date : | June 2010 |
| Actual Study Completion Date : | July 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Hormone therapy, estramustine, etoposide and paclitaxel
Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel
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Drug: bicalutamide Drug: estramustine Other Name: estramustine phosphate sodium Drug: etoposide Drug: flutamide Drug: goserelin Drug: leuprolide Other Name: leuprolide acetate Drug: nilutamide Drug: paclitaxel |
Primary Outcome Measures :
- Progression-free Survival [ Time Frame: 0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression) ]Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of >=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.
- Overall Survival (OS) [ Time Frame: 0-5 years ]Overall survival is defined from the date of registration to date of death from any cause
Secondary Outcome Measures :
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: up to 5 years after registration ]Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
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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
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate
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Clinical stage D2 disease as evidenced by one of the following:
- Visceral disease (liver, lung, or other viscera)
- Bone metastases to sites in both the axial (spine, pelvis, ribs, or skull) and appendicular (claviculae, humeri, or femora) skeleton
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No prior or concurrent (treated or untreated) brain metastases
- Patients with clinical evidence of brain metastasis must have a negative brain CT or MRI
- No evidence of untreated spinal cord compression
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No active hypercoagulability
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No transient ischemic attacks, stroke, or myocardial infarction within the past 6 months
- No active coronary artery disease requiring antianginal therapy
- No active thrombophlebitis
Pulmonary:
- No history of pulmonary embolus
Other:
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy and recovered
- No concurrent biologic therapy
Chemotherapy:
- No prior cytotoxic chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Prior androgen-blockade therapy (e.g., luteinizing hormone-releasing hormone agonist and antiandrogen therapy) allowed if administered for a duration of less than 30 days
- Prior neoadjuvant hormonal therapy allowed
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- At least 4 weeks since prior surgery and recovered
Other:
- No concurrent bisphosphonates
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): NCT00028769
Locations
Show 91 study locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
| Study Chair: | David C. Smith, MD | University of Michigan Rogel Cancer Center |
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00028769 |
| Other Study ID Numbers: |
CDR0000069132 S0032 ( Other Identifier: SWOG ) U10CA032102 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Results First Posted: | July 16, 2013 |
| Last Update Posted: | July 16, 2013 |
| Last Verified: | June 2013 |
Keywords provided by Southwest Oncology Group:
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adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Paclitaxel Etoposide Leuprolide Goserelin Bicalutamide Flutamide Estramustine Nilutamide Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Antineoplastic Agents, Hormonal Androgen Antagonists Hormone Antagonists |