S9916, Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
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| ClinicalTrials.gov Identifier: NCT00004001 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : February 25, 2014
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Sponsor:
SWOG Cancer Research Network
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
North Central Cancer Treatment Group
Information provided by (Responsible Party):
SWOG Cancer Research Network
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Brief Summary:
RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether estramustine plus docetaxel is more effective than mitoxantrone plus prednisone for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of estramustine plus docetaxel with that of mitoxantrone plus prednisone in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: docetaxel Drug: estramustine Drug: mitoxantrone Drug: prednisone | Phase 3 |
OBJECTIVES:
- Compare the overall survival and progression-free survival in patients with hormone-refractory, metastatic adenocarcinoma of the prostate treated with docetaxel and estramustine vs mitoxantrone and prednisone.
- Compare the qualitative and quantitative toxic effects of these regimens in this patient population.
- Compare the quality of life, including palliation of metastatic bone pain and global quality of life, of patients treated with these regimens.
- Record prostate-specific antigen values for future correlations with response and survival in patients treated with these regimens.
- Compare the responses in patients with bidimensionally measurable disease treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (measurable or evaluable disease progression vs rising PSA only), NCI Common Toxicity Criteria version 2.X pain scale (grade 2 or greater vs less than 2), and SWOG performance status (0-1 vs 2-3). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2.
- Arm II: Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21.
Treatment in both arms repeats every 3 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.
Quality of life is assessed at baseline, after courses 4 and 8, and then at 1 year after randomization.
Patients are followed every 6 months for 2 years and then annually for 1 year.
PROJECTED ACCRUAL: A total of 620 patients (310 per arm) will be accrued for this study within 3.5 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 770 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer |
| Study Start Date : | October 1999 |
| Actual Primary Completion Date : | July 2006 |
| Actual Study Completion Date : | January 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Docetaxel and Estramustine
Estramustine, 280 mg, PO, TID, Days 1-5; q 21 days Docetaxel, 60mg/m2, IV, Day 2; q 21 days
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Drug: docetaxel Drug: estramustine |
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Active Comparator: Mitoxantrone and Prednisone
Mitoxantrone, 12 mg/m2, IV, Day 1; q 21 days Prednisone, 5 mg, PO, BID, Days 1-21; q 21 days
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Drug: mitoxantrone Drug: prednisone |
Primary Outcome Measures :
- Compare overall survival in the two study arms [ Time Frame: up to 4 years ]Measured from date of registration to date of death due to any cause
Secondary Outcome Measures :
- Compare progression-free survival between two study arms [ Time Frame: up to 4 years ]Measured from date of registration to date of first observation of progression disease, or death due to any cause
- Compare Prostate-Specific Antigen (PSA) response between two study arms [ Time Frame: up to 4 years or time of disease progression ]A confirmed partial response of non-measurable disease was defined as a reduction by more than 50% over baseline in two or more Prostate-Specific Antigen (PSA) measurements obtained at least four weeks apart, with no evidence of disease progression on imaging. Progressive disease was defined as a 25% increase in the serum PSA level - to at least 5 ng per milliliter - over the last preregistration measurement, with confirmation of the increase at least four weeks later. For patients with a decrease in serum PSA levels during the trial, progressive disease was defined as a confirmed increase of 25%, to at least 5 ng per milliliter over the nadir.
- Compare objective responses between two study arms [ Time Frame: up to 12 cycles of treatment ( 1cycle = 21 days) ]Objective responses were defined on the basis of the sum of bi-dimensional measurements of metastatic lesions. Confirmed objective responses required a follow-up scan (a minimum of four weeks later) that demonstrated a continued response. Progression was defined by one of the following: a 50 percent increase or an increase of 10 cm^2, whichever was smaller, in the sum of measurements of metastatic lesions over the sum at baseline; a clear worsening of nonmeasurable disease; reappearance of any lesion that had disappeared; appearance of any new lesion; or death.
- Compare toxicities between the two study arms [ Time Frame: up to 12 cycles of treatment (1 cycle = 21 days) ]
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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:
- Histologically confirmed metastatic adenocarcinoma of the prostate
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Unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria:
- Progression of bidimensionally measurable disease
- Progression of evaluable but not measurable disease (bone scan)
- At least 2 consecutive rises in PSA and a PSA level of at least 5 ng/mL
- No minimum PSA required for measurable disease or non-PSA evaluable disease
- Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
- Prior orchiectomy OR
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Medical castration using leuprolide or goserelin
- Luteinizing hormone-releasing hormone (LHRH) agonist therapy must continue during study
- Prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or nilutamide) allowed if disease progression occurred
- No third-space fluid accumulation such as ascites or symptomatic pleural effusion
- No brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- SWOG 0-3
- Performance status 3 must be due to pain secondary to bone metastases
Life expectancy:
- Not specified
Hematopoietic:
- No hypercoagulability
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No history of myocardial infarction
- No history of congestive heart failure unless well controlled
- No history of cerebrovascular accident or atrial fibrillation
- No active thrombophlebitis
- Left ventricular ejection fraction (LVEF) at least 50% by Multi Gated Acquisition Scan (MUGA) scan or 2-D echocardiogram
Pulmonary:
- No history of pulmonary embolus
Other:
- Recovered from major infections
- No other significant active medical illness
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or 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 more than 1 prior biologic therapy regimen
- No concurrent biological response modifiers
Chemotherapy:
- At least 4 weeks since prior chemotherapy and recovered
- No more than 1 prior chemotherapy regimen
- No prior estramustine, taxanes, anthracyclines, or mitoxantrone
- No other concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- At least 4 weeks since prior flutamide or ketoconazole (6 weeks for bicalutamide or nilutamide)
- No concurrent corticosteroids or hormonal therapy (except megestrol for hot flashes or continuing LHRH treatment)
Radiotherapy:
- See Disease Characteristics
- Prior samarium Sm 153 lexidronam pentasodium allowed
- At least 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to 30% or more of bone marrow
- No prior strontium chloride Sr 89
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 3 weeks since prior surgery and recovered
Other:
- At least 4 weeks since prior bisphosphonates
- No prior anticoagulation therapy (i.e., warfarin), except aspirin
- 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): NCT00004001
Locations
| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Illinois | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| CentraCare Health Plaza | |
| Saint Cloud, Minnesota, United States, 56303 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| United States, North Dakota | |
| Medcenter One Health System | |
| Bismarck, North Dakota, United States, 58501 | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Altru Health System | |
| Grand Forks, North Dakota, United States, 58201 | |
| United States, Pennsylvania | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
Sponsors and Collaborators
SWOG Cancer Research Network
National Cancer Institute (NCI)
Cancer and Leukemia Group B
North Central Cancer Treatment Group
Investigators
| Study Chair: | Daniel P. Petrylak, MD | Herbert Irving Comprehensive Cancer Center | |
| Study Chair: | Eric J. Small, MD | University of California, San Francisco | |
| Study Chair: | Patrick A. Burch, MD | Mayo Clinic |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Berry DL, Moinpour CM, Jiang C, et al.: Quality of life (QOL) and pain in advanced stage prostate cancer: impact of missing data on evaluating palliation in SWOG 9916. [Abstract] J Clin Oncol 22 (Suppl 14): A-4579, 401s, 2004.
Crawford ED, Pauler DK, Tangen CM, et al.: Three-month change in PSA as a surrogate endpoint for mortality in advanced hormone-refractory prostate cancer (HRPC): data from Southwest Oncology Group study S9916. [Abstract] J Clin Oncol 22 (Suppl 14): A-4505, 383s, 2004.
Petrylak DP, Tangen C, Hussain M, et al.: SWOG 99-16: randomized phase III trial of docetaxel (D)/estramustine (E) versus mitoxantrone(M)/prednisone(p) in men with androgen-independent prostate cancer (AIPCA). [Abstract] J Clin Oncol 22 (Suppl 14): A-3, 2s, 2004.
Other Publications:
Goldman B, Hussain M, Tangen C, et al.: Prostate-specific antigen progression (PSA-P) as a predictor of overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-165, 2008.
Hussain MH, Goldman B, Tangen CM, et al.: Use of prostate-specific antigen progression (PSA-P) to predict overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916. [Abstract] J Clin Oncol 26 (Suppl 15): A-5015, 2008.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | SWOG Cancer Research Network |
| ClinicalTrials.gov Identifier: | NCT00004001 |
| Other Study ID Numbers: |
CDR0000067211 S9916 ( Other Identifier: SWOG ) U10CA032102 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | February 25, 2014 |
| Last Verified: | February 2014 |
Keywords provided by SWOG Cancer Research Network:
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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 Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Prednisone Docetaxel Mitoxantrone Estramustine Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Analgesics Sensory System Agents Peripheral Nervous System Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors |