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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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


- Determine the objective response rate in patients with hormone-refractory prostate
cancer treated with docetaxel, estramustine, and thalidomide.

- Determine the safety and toxicity of this regimen in these patients.

- Determine the efficacy of this regimen for pain control in these patients.

OUTLINE: Patients receive oral estramustine on days 1-3 and docetaxel IV over 1 hour on day
2 for 3 weeks. Treatment repeats every 4 weeks for at least 6 courses in the absence of
disease progression or unacceptable toxicity.

Patients also receive oral thalidomide once daily beginning on day 1 and continuing for 1
year in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly until disease progression.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.

Inclusion Criteria


- 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)

- 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

- 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



- Over 18

Performance status:

- Karnofsky 70-100%

Life expectancy:

- More than 16 weeks


- 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


- 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


- Creatinine less than 2.2 mg/dL


- 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


- No history of pulmonary embolism


- 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


Biologic therapy:

- Not specified


- 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


- At least 4 weeks since prior radiotherapy


- See Disease Characteristics


- No concurrent herbal supplements to treat prostate cancer

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment

Safety Issue:


Principal Investigator

Richard C. Frank, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Whittingham Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2001

Completion Date:

October 2009

Related Keywords:

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



Carl and Dorothy Bennett Cancer Center at Stamford Hospital Stamford, Connecticut  06904
Whittingham Cancer Center at Norwalk Hospital Norwalk, Connecticut  06856