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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00052845 |
Purpose
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Estramustine may fight prostate cancer by reducing the production of androgens. Exisulind may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining these therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining estramustine with exisulind and docetaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: docetaxel Drug: estramustine phosphate sodium Drug: exisulind |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Estramustine, Docetaxel, And Exisulind (IND #64733) In Men With Hormone Refractory Prostate Cancer |
| Enrollment: | 80 |
| Study Start Date: | November 2002 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combined chemotherapy
combination of 3 chemotherapy agents for hormone refractory prostate cancer
|
Drug: docetaxel
70 mg/sq m IV infusion over 1 hour Day 2 of ea cycle
Drug: estramustine phosphate sodium
280 mg PO tid Days 1-5 of ea cycle
Drug: exisulind
Two 125 mg capsules PO bid Days 1-21 of ea cycle
|
OBJECTIVES:
OUTLINE: Patients receive oral estramustine 3 times daily on days 1-5, docetaxel IV over 1 hour on day 2, and oral exisulind twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Progressive systemic (metastatic) disease despite castrate levels of testosterone secondary to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy
Evidence of progressive disease after most recent prior therapy (including hormonal therapy) as defined by 1 of the following:
Measurable disease progression
Bone scan progression
PSA progression
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No other concurrent hormonal therapy except:
Radiotherapy
Surgery
Other
No concurrent chronic nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors and salicylates such as aspirin, mesalamine, salsalate, and sulfasalazine)
Contacts and Locations
Show 80 Study Locations| Study Chair: | Nancy A. Dawson, MD | University of Maryland Greenebaum Cancer Center |
More Information
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00052845 History of Changes |
| Other Study ID Numbers: | CDR0000258766, U10CA031946, CALGB-90004 |
| Study First Received: | January 24, 2003 |
| Last Updated: | April 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Estramustine Sulindac sulfone Docetaxel Hormones Sodium phosphate Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cathartics Gastrointestinal Agents Anticarcinogenic Agents Protective Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |