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S9916, Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy

Information source: Southwest Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: docetaxel (Drug); estramustine (Drug); mitoxantrone (Drug); prednisone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
Daniel P. Petrylak, MD, Study Chair, Affiliation: Herbert Irving Comprehensive Cancer Center
Eric J. Small, MD, Study Chair, Affiliation: University of California, San Francisco
Patrick A. Burch, MD, Study Chair, Affiliation: Mayo Clinic

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.

Clinical Details

Official title: Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Compare overall survival in the two study arms

Secondary outcome:

Compare progression-free survival between two study arms

Compare Prostate-Specific Antigen (PSA) response between two study arms

Compare objective responses between two study arms

Compare toxicities between the two study arms

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic adenocarcinoma of the prostate

- 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

- 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

Locations and Contacts

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States

Mayo Clinic, Jacksonville, Florida 32224, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States

Siouxland Hematology-Oncology, Sioux City, Iowa 51101-1733, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

CentraCare Health Plaza, Saint Cloud, Minnesota 56303, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

Medcenter One Health System, Bismarck, North Dakota 58501, United States

CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States

Altru Health System, Grand Forks, North Dakota 58201, United States

CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania 17822-2001, United States

Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Related publications:

Hussain M, Goldman B, Tangen C, Higano CS, Petrylak DP, Wilding G, Akdas AM, Small EJ, Donnelly BJ, Sundram SK, Burch PA, Dipaola RS, Crawford ED. Prostate-specific antigen progression predicts overall survival in patients with metastatic prostate cancer: data from Southwest Oncology Group Trials 9346 (Intergroup Study 0162) and 9916. J Clin Oncol. 2009 May 20;27(15):2450-6. doi: 10.1200/JCO.2008.19.9810. Epub 2009 Apr 20.

de Wit R. Chemotherapy in hormone-refractory prostate cancer. BJU Int. 2008 Mar;101 Suppl 2:11-5. doi: 10.1111/j.1464-410X.2007.07485.x. Review.

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.

Calabrò F, Sternberg CN. Current indications for chemotherapy in prostate cancer patients. Eur Urol. 2007 Jan;51(1):17-26. Epub 2006 Aug 22. Review.

Chowdhury S, Burbridge S, Harper PG. Chemotherapy for the treatment of hormone-refractory prostate cancer. Int J Clin Pract. 2007 Dec;61(12):2064-70. Epub 2007 Oct 23. Review.

Mendiratta P, Armstrong AJ, George DJ. Current standard and investigational approaches to the management of hormone-refractory prostate cancer. Rev Urol. 2007;9 Suppl 1:S9-S19.

Montgomery RB, Goldman B, Tangen CM, Hussain M, Petrylak DP, Page S, Klein EA, Crawford ED; Southwest Oncology Group. Association of body mass index with response and survival in men with metastatic prostate cancer: Southwest Oncology Group trials 8894 and 9916. J Urol. 2007 Nov;178(5):1946-51; discussion 1951. Epub 2007 Sep 17.

Burgess EF, Roth BJ. Changing perspectives of the role of chemotherapy in advanced prostate cancer. Urol Clin North Am. 2006 May;33(2):227-36, vii. Review.

Lucas A, Petrylak DP. The case for early chemotherapy for the treatment of metastatic disease. J Urol. 2006 Dec;176(6 Pt 2):S72-5. Review.

Moss RA, Petrylak DP. Cytotoxic chemotherapy for prostate cancer: Who and when? Curr Treat Options Oncol. 2006 Sep;7(5):370-7. Review.

McKeage K, Keam SJ. Docetaxel in hormone-refractory metastatic prostate cancer. Drugs. 2005;65(16):2287-94; discussion 2295-7. Review.

Starting date: October 1999
Last updated: February 21, 2014

Page last updated: August 23, 2015

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