A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Prior treatment with androgen ablation including:

- Orchiectomy OR

- Luteinizing hormone-releasing hormone (LHRH) therapy (e.g., leuprolide)

- Patients on leuprolide must continue to receive the drug

- Prior nonsteroidal antiandrogens (e.g., flutamide, bicalutamide, or nilutamide)
required

- Metastatic disease with disease progression during androgen ablation, defined by at
least 1 of the following:

- 2 consecutive increased prostate-specific antigen (PSA) levels measured at least
1 week apart

- More than 25% increase in bidimensionally measurable soft tissue metastases

- 20% increase in the sum of the baseline sum of longest diameter of measurable
lesions

- Appearance of new lesions

- Appearance of new foci on a radionuclide bone scan

- PSA greater than 10 ng/dL

- Testosterone no greater than 50 ng/mL (castrate level)

- No CNS metastases

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- Karnofsky 70-100%

Life expectancy:

- More than 16 weeks

Hematopoietic:

- WBC greater than 3,500/mm3

- Absolute neutrophil count greater than 1,500/mm3

- Platelet count greater than 100,000/mm3

- Hemoglobin at least 8 g/dL

Hepatic:

- AST and/or ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline
phosphatase no greater than ULN OR

- Alkaline phosphatase no greater than 4 times ULN if AST/ALT no greater than ULN

- Bilirubin no greater than ULN

Renal:

- Creatinine less than 2.2 mg/dL

Cardiovascular:

- No myocardial infarction within the past 6 months

- No New York Heart Association class III or IV heart disease

- No history of arterial or venous thrombosis

- No cerebrovascular accident within the past year

Pulmonary:

- No history of pulmonary embolism

Other:

- Fertile patients must use effective contraception during and for 4 weeks after study

- No peripheral neuropathy grade 2 or greater

- No active infection

- No serious concurrent medical illness that would preclude study

- No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with
polysorbate 80

- No other prior or concurrent active malignancy within the past 2 years except
non-melanoma skin cancers

- No other medical condition or reason that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for prostate cancer

Endocrine therapy:

- See Disease Characteristics

- At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and
continued evidence of disease progression (rising PSA)

- Prior steroids for prostate cancer allowed

- No concurrent steroids except for pre-medication for docetaxel

Radiotherapy:

- At least 4 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

Other:

- No concurrent herbal supplements to treat prostate cancer