Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Giving chemotherapy together with thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma (cancer) of the prostate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Androgens; Docetaxel; Estramustine; Thalidomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Metastatic disease

• Androgen-independent disease

• Clinically progressive disease documented by at least 1 of the following parameters:

• Two consecutively rising prostate-specific antigen (PSA) levels taken at least 1 week apart

• PSA ≥ 5.0 ng/mL

• Continued rise in PSA 4 weeks after discontinuation of prior flutamide OR 6 weeks after discontinuation of prior bicalutamide or nilutamide (for patients treated with anti-androgen agents)

• At least 1 new lesion on bone scan

• Progressive measurable disease

• Must have undergone bilateral surgical castration OR continue on a gonadotropin-releasing hormone agonist

• No brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,500/mm^3

• Platelet count ≥ 100,000/mm^3*

• Hemoglobin ≥ 7.5 g/dL* NOTE: *No transfusions within the past 2 weeks

Hepatic

• AST and ALT < 2.5 times upper limit of normal (ULN)

• Bilirubin < ULN (≤ 3.0 times ULN for patients with Gilbert's syndrome)

• Alkaline phosphatase ≤ 2.5 times ULN OR

• Fractionated hepatic alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 mg/dL OR

• Creatinine clearance ≥ 40 mL/min

Cardiovascular

• No transient ischemic attacks or cerebrovascular accident within the past 2 years

• No myocardial infarction within the past 6 months

• No uncontrolled congestive heart failure

• No uncontrolled angina pectoris

• No thromboembolic disease

Other

• No peripheral neuropathy ≥ grade 2

• No cognitive impairment that would preclude study participation or giving informed consent

• No other active malignancy within the past 2 years except non-melanoma skin cancer or superficial bladder carcinoma

• Fertile patients must use effective contraception for at least 1 month before, during, and for at least 1 month after study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior thalidomide

Chemotherapy

• No prior docetaxel

• No prior estramustine

• No prior chemotherapy for metastatic prostate cancer

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• Recovered from prior radiotherapy

Surgery

• See Disease Characteristics

• Recovered from prior surgery

Other

• No concurrent antiretroviral therapy for HIV-positive patients

• No concurrent complementary or alternative therapy that would interact with study drugs

• No concurrent herbal or nutritional products or dietary supplements that would interact with study drugs

• No concurrent aprepitant as secondary prophylaxis or antiemetic treatment