Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00002855
First received: November 1, 1999
Last updated: July 27, 2012
Last verified: July 2012
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Bicalutamide Drug: Doxorubicin hydrochloride Drug: Estramustine Phosphate Sodium Drug: Flutamide Drug: Ketoconazole Drug: Nilutamide Drug: Therapeutic Hydrocortisone Drug: Vinblastine Procedure: Conventional Surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate |
Resource links provided by NLM:
Drug Information available for:
Hydrocortisone acetate
Hydrocortisone
Hydrocortisone sodium succinate
Vinblastine sulfate
Hydrocortisone cypionate
Vinblastine
Sodium phosphate, dibasic
Flutamide
Hydrocortisone butyrate
Doxorubicin
Doxorubicin hydrochloride
Estramustine phosphate sodium
Hydrocortisone valerate
Nilutamide
Ketoconazole
Hydrocortisone probutate
Proctofoam-HC
Bicalutamide
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Time to Progression [ Time Frame: From baseline to post treatment (minimally 24+ weeks) ] [ Designated as safety issue: No ]
| Enrollment: | 306 |
| Study Start Date: | August 1996 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Arm I: Medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
|
Drug: Bicalutamide
Other Name: Casodex
Drug: Flutamide
Other Name: Eulexin
Drug: Nilutamide
Other Names:
Procedure: Conventional Surgery
Surgical castration
Other Name: Castration
|
|
Experimental: Arm II
Arm II: Chemo/hormonal therapy for 3 x 8-week courses, followed by total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 weeks rest. Maintained on hydrocortisone both during treatment and during rest.
|
Drug: Doxorubicin hydrochloride
Other Names:
Drug: Estramustine Phosphate Sodium
Other Name: Emcyt
Drug: Ketoconazole
Other Name: Nizoral
Drug: Therapeutic Hydrocortisone
Other Names:
Drug: Vinblastine
Other Name: Velban
|
Detailed Description:
OBJECTIVES:
- Determine the clinical benefit, as measured by time to progression and overall survival, of chemo/hormonal therapy compared to androgen ablation alone, when given as the initial systemic treatment in patients with acinar adenocarcinoma of the prostate that is not amenable to local therapy.
- Validate the clinical significance of PSA criteria for progression.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients are treated with medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
- Arm II: Patients receive chemo/hormonal therapy for 3 eight week courses, followed by total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 weeks of rest. These patients are also maintained on hydrocortisone both during treatment and during rest.
Patients in arm II have a long-term central venous access device inserted.
PROJECTED ACCRUAL: A total of 368 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically proven acinar adenocarcinoma of the prostate
- Metastatic or locally advanced disease that either is not appropriately treated with surgery or radiation, or has recurred following previous "definitive" local therapy
- No CNS metastases
- No histologic subtypes, such as pure ductal or any component of small cell carcinoma
- Elevated PSA (at least 1.0 ng/mL in patients with prior prostatectomy or 4.0 ng/mL in those with prostate in place)
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- At least 3 years
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Conjugated bilirubin no greater than 0.8 mg/dL or total bilirubin no greater than 1.5 mg/dL
- Transaminase no greater than 4 times upper limit of normal
Renal:
- Creatinine clearance at least 40 mL/min
Cardiovascular:
- No evidence of bifascicular block on EKG
- No evidence of active ischemia on EKG
- No prior history of transient ischemic attack
- No evidence of congestive heart failure
Other:
- No active peptic ulcer disease
- No regular use of antacid or H2 blockers
- No known or predicted achlorhydria
- No concurrent use of terfenadine, astemizole, omeprazole, or cisapride
- No second malignancy unless curatively treated
- No history of deep venous thrombosis
- No history of pulmonary embolism
- No serious co-morbidity
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior cytotoxic systemic therapy
Endocrine therapy:
- Prior androgen deprivation therapy allowed if given for no more than 6 months to downstage primary
- No androgen deprivation therapy within 1 year prior to study
Radiotherapy:
- No prior cytotoxic systemic therapy (including systemic strontium-89 irradiation)
- Prior definitive radiotherapy to the prostate and/or one metastatic site allowed
- At least 8 weeks since radiotherapy to the pelvis
- At least 3 weeks since radiotherapy to a single metastatic site
Surgery:
- Prior prostatectomy allowed
Other:
- No concurrent anti-anginal therapy or aggressive anticoagulants
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002855
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002855
Locations
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Randall E. Millikan, MD, PhD | M.D. Anderson Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00002855 History of Changes |
| Other Study ID Numbers: | DM95-231, P30CA016672, MDA-DM-95231, NCI-G96-1044, CDR0000065105 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Diseases, Male Genital Neoplasms, Male Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Neoplasms Androgens Bicalutamide Cortisol succinate Doxorubicin Estramustine Flutamide Hydrocortisone Hydrocortisone 17-butyrate 21-propionate |
Hydrocortisone acetate Hydrocortisone-17-butyrate Ketoconazole Liposomal doxorubicin Nilutamide Vinblastine 14-alpha Demethylase Inhibitors Alkylating Agents Androgen Antagonists Anti-Infective Agents Anti-Inflammatory Agents Antibiotics, Antineoplastic Antifungal Agents Antimitotic Agents Antineoplastic Agents |
ClinicalTrials.gov processed this record on February 25, 2015