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A Randomized Phase II Trial of Taxol/VP-16/Estramustine vs. Ketoconazole/Doxorubicin/Vinblastine/Estramustine in Androgen Independent Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Randomized Phase II Trial of Taxol/VP-16/Estramustine vs. Ketoconazole/Doxorubicin/Vinblastine/Estramustine in Androgen Independent Prostate Cancer

OBJECTIVES: I. Determine the clinical benefit of two combination chemotherapy regimens,
paclitaxel, etoposide, and estramustine vs ketoconazole, doxorubicin, vinblastine, and
estramustine in patients with androgen independent prostate cancer, as measured by prostate
specific antigen (PSA)-based response rate, time to progression, and overall survival. II.
Identify the most promising regimen to use in a phase III trial based on toxic effects,
PSA-based response rates, and clinical benefit.

OUTLINE: This is a randomized multicenter study. Patients are stratified according to risk
group: low volume disease (no more than 2 lesions on bone scan), intermediate volume (more
than 2 bone lesions confined to axial skeleton), or high volume (bone lesions in
appendicular skeletal or visceral lesions). Patients are randomized to one of two treatment
arms. Arm I: Patients receive oral estramustine three times a day and oral etoposide twice
daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Treatment repeats every 21 days.
Arm II: Patients receive doxorubicin IV on days 1, 15, and 29, vinblastine IV on days 8, 22,
and 36, oral ketoconazole three times a day on days 1-7, 15-21, and 29-35, and oral
estramustine three times a day on days 8-14, 22-28, and 36-42. This regimen consists of 6
weeks of alternating chemotherapy and 2 weeks rest, for an 8 week course. Treatment
continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm) will be accrued for this

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Androgen
independent disease progression -Castrate testosterone level of less than 40 ng/dL (if
medically achieved, treatment must be maintained continuously) -Prostate specific antigen
(PSA) at least 4 ng/mL and rising on at least 2 consecutive measurements No variant
histologies such as ductal carcinoma (endometrioid or cribiform) or small cell carcinoma
Brain metastases controlled

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-3 Life expectancy:
At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet
count at least 100,000/mm3 Hemoglobin greater than 9.5 g/dL (without transfusion support)
Hepatic: Bilirubin and transaminase less than 2 times the upper limit of normal Renal:
Creatinine no greater than 2.0 mg/dL OR Estimated creatinine clearance at least 35 mL/min
Cardiovascular: No clinical history of heart disease Normal ECG OR Ejection fraction
(ECHO, MUGA, or ventriculography) at least 45% Other: Spinal cord compression controlled
No active peptic ulcer disease No active, or likely to become active, second malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior ketoconazole Chemotherapy: No prior
doxorubicin, vinblastine, estramustine, paclitaxel, or etoposide No greater than one prior
cytotoxic therapy No other concurrent chemotherapy At least 8 weeks since prior mitomycin
At least 60 days since prior suramin Endocrine therapy: No antiandrogen therapy such as
flutamide or nilutamide within 4 weeks (6 weeks for bicalutamide) without response OR
Progression since antiandrogen withdrawal Prior dexamethasone therapy discontinued
Radiotherapy: At least 10 weeks since prior strontium Sr 89 and no more than 1 prior
regimen No concurrent strontium Sr 89 Surgery: Not specified Other: No other concurrent
therapy for prostate cancer No concurrent H2 blockers, omeprazole, or antacids No
concurrent terfenadine and astemizole

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prostate specific antigen (PSA)- based Response Rate

Outcome Time Frame:

8 week cycle

Safety Issue:


Principal Investigator

Randall E. Millikan, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1997

Completion Date:

November 2002

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Chemotherapy
  • Ketoconazole
  • Estramustine
  • Etoposide
  • Paclitaxel
  • Doxorubicin
  • Vinblastine
  • Prostatic Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009