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Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer


OBJECTIVES:

- Compare the overall survival and progression-free survival in patients with
hormone-refractory, metastatic adenocarcinoma of the prostate treated with docetaxel
and estramustine vs mitoxantrone and prednisone.

- Compare the qualitative and quantitative toxic effects of these regimens in this
patient population.

- Compare the quality of life, including palliation of metastatic bone pain and global
quality of life, of patients treated with these regimens.

- Record prostate-specific antigen values for future correlations with response and
survival in patients treated with these regimens.

- Compare the responses in patients with bidimensionally measurable disease treated with
these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease status (measurable or evaluable disease progression vs rising PSA only), NCI Common
Toxicity Criteria version 2.X pain scale (grade 2 or greater vs less than 2), and SWOG
performance status (0-1 vs 2-3). Patients are randomized to one of two treatment arms.

- Arm I: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV
over 1 hour on day 2.

- Arm II: Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone
twice daily on days 1-21.

Treatment in both arms repeats every 3 weeks for a maximum of 12 courses in the absence of
unacceptable toxicity or disease progression.

Quality of life is assessed at baseline, after courses 4 and 8, and then at 1 year after
randomization.

Patients are followed every 6 months for 2 years and then annually for 1 year.

PROJECTED ACCRUAL: A total of 620 patients (310 per arm) will be accrued for this study
within 3.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic adenocarcinoma of the prostate

- Unresponsive or refractory to hormonal therapy, as defined by at least 1 of the
following criteria:

- Progression of bidimensionally measurable disease

- Progression of evaluable but not measurable disease (bone scan)

- At least 2 consecutive rises in PSA and a PSA level of at least 5 ng/mL

- No minimum PSA required for measurable disease or non-PSA evaluable disease

- Soft tissue disease that has been irradiated within the past 2 months is not
considered measurable disease

- Prior orchiectomy OR

- Medical castration using leuprolide or goserelin

- LHRH agonist therapy must continue during study

- Prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or
nilutamide) allowed if disease progression occurred

- No third-space fluid accumulation such as ascites or symptomatic pleural effusion

- No brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- SWOG 0-3

- Performance status 3 must be due to pain secondary to bone metastases

Life expectancy:

- Not specified

Hematopoietic:

- No hypercoagulability

Hepatic:

- Not specified

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No history of myocardial infarction

- No history of congestive heart failure unless well controlled

- No history of cerebrovascular accident or atrial fibrillation

- No active thrombophlebitis

- LVEF at least 50% by MUGA scan or 2-D echocardiogram

Pulmonary:

- No history of pulmonary embolus

Other:

- Recovered from major infections

- No other significant active medical illness

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior biologic therapy and recovered

- No more than 1 prior biologic therapy regimen

- No concurrent biological response modifiers

Chemotherapy:

- At least 4 weeks since prior chemotherapy and recovered

- No more than 1 prior chemotherapy regimen

- No prior estramustine, taxanes, anthracyclines, or mitoxantrone

- No other concurrent chemotherapy

Endocrine therapy:

- See Disease Characteristics

- At least 4 weeks since prior flutamide or ketoconazole (6 weeks for bicalutamide or
nilutamide)

- No concurrent corticosteroids or hormonal therapy (except megestrol for hot flashes
or continuing LHRH treatment)

Radiotherapy:

- See Disease Characteristics

- Prior samarium Sm 153 lexidronam pentasodium allowed

- At least 4 weeks since prior radiotherapy and recovered

- No prior radiotherapy to 30% or more of bone marrow

- No prior strontium chloride Sr 89

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 3 weeks since prior surgery and recovered

Other:

- At least 4 weeks since prior bisphosphonates

- No prior anticoagulation therapy (i.e., warfarin), except aspirin

- No concurrent bisphosphonates

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Daniel P. Petrylak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067211

NCT ID:

NCT00004001

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - Merit Care HospitalFargo, North Dakota  58122
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Mayo ClinicJacksonville, Florida  32224
Medcenter One Health SystemBismarck, North Dakota  58501
CentraCare Health PlazaSaint Cloud, Minnesota  56303
Altru Health SystemGrand Forks, North Dakota  58201