Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

NCT00002855 | Completed Phase 3

• 5 other identifiers: DM95-231P30CA016672MDA-DM-95231NCI-G96-1044CDR0000065105
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  From baseline to post treatment (minimally 24+ weeks)

Study Arms (2)

Arm I

EXPERIMENTAL

Arm I: Medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.

Drug: Bicalutamide; Drug: Flutamide; Drug: Nilutamide; Procedure: Conventional Surgery

Arm II

EXPERIMENTAL

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; Drug: Estramustine Phosphate Sodium; Drug: Ketoconazole; Drug: Therapeutic Hydrocortisone; Drug: Vinblastine

Interventions

Bicalutamide DRUG

Also known as: Casodex

Arm I

Doxorubicin hydrochloride DRUG

Also known as: Adriamycin, Adriamycin PFS, Adriamycin RDF, Rubex

Arm II

Estramustine Phosphate Sodium DRUG

Also known as: Emcyt

Arm II

Flutamide DRUG

Also known as: Eulexin

Arm I

Ketoconazole DRUG

Also known as: Nizoral

Arm II

Nilutamide DRUG

Also known as: Anandron, Nilandron

Arm I

Therapeutic Hydrocortisone DRUG

Also known as: A-hydroCort, Cortef, Cortenema, Cortifoam, Hydrocortone, Solu-Cortef

Arm II

Vinblastine DRUG

Also known as: Velban

Arm II

Conventional Surgery PROCEDURE

Surgical castration

Also known as: Castration

Arm I

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• Millikan RE, Wen S, Pagliaro LC, Brown MA, Moomey B, Do KA, Logothetis CJ. Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer. J Clin Oncol. 2008 Dec 20;26(36):5936-42. doi: 10.1200/JCO.2007.15.9830. Epub 2008 Nov 24.

  PMID: 19029421 RESULT

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Doxorubicin; Estramustine; Flutamide; Ketoconazole; nilutamide; Hydrocortisone; hydrocortisone acetate; hydrocortisone hemisuccinate; Vinblastine; Castration

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Anilides; Amides; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures

Study Officials

• Randall E. Millikan, MD, PhD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: August 1, 1996
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)