search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bicalutamide
Doxorubicin hydrochloride
Estramustine Phosphate Sodium
Flutamide
Ketoconazole
Nilutamide
Therapeutic Hydrocortisone
Vinblastine
Conventional Surgery
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas - MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Time to Progression

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
October 30, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00002855
Brief Title
Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
Official Title
A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 1996 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Arm I: Medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Other Intervention Name(s)
Casodex
Intervention Type
Drug
Intervention Name(s)
Doxorubicin hydrochloride
Other Intervention Name(s)
Adriamycin, Adriamycin PFS, Adriamycin RDF, Rubex
Intervention Type
Drug
Intervention Name(s)
Estramustine Phosphate Sodium
Other Intervention Name(s)
Emcyt
Intervention Type
Drug
Intervention Name(s)
Flutamide
Other Intervention Name(s)
Eulexin
Intervention Type
Drug
Intervention Name(s)
Ketoconazole
Other Intervention Name(s)
Nizoral
Intervention Type
Drug
Intervention Name(s)
Nilutamide
Other Intervention Name(s)
Anandron, Nilandron
Intervention Type
Drug
Intervention Name(s)
Therapeutic Hydrocortisone
Other Intervention Name(s)
A-hydroCort, Cortef, Cortenema, Cortifoam, Hydrocortone, Solu-Cortef
Intervention Type
Drug
Intervention Name(s)
Vinblastine
Other Intervention Name(s)
Velban
Intervention Type
Procedure
Intervention Name(s)
Conventional Surgery
Other Intervention Name(s)
Castration
Intervention Description
Surgical castration
Primary Outcome Measure Information:
Title
Time to Progression
Time Frame
From baseline to post treatment (minimally 24+ weeks)

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall E. Millikan, MD, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19029421
Citation
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.
Results Reference
result
Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs