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Phase II Randomized Study of Docetaxel With or Without Thalidomide in Patients With Androgen-Independent Metastatic Prostate Cancer

Phase 2
18 Years
Not Enrolling
Stage IV Prostate Cancer, Adenocarcinoma of the Prostate, Recurrent Prostate Cancer

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Trial Information

Phase II Randomized Study of Docetaxel With or Without Thalidomide in Patients With Androgen-Independent Metastatic Prostate Cancer

OBJECTIVES: I. Determine the efficacy of thalidomide with docetaxel in terms of clinical
response in patients with androgen-independent metastatic prostate cancer.

II. Compare the pharmacokinetics of docetaxel with or without thalidomide in these patients
III. Determine whether any pharmacodynamic relationships exist between plasma
concentrations and clinical activity or toxicity of these regimens in this patient

IV. Compare changes in molecular markers of angiogenesis and markers of apoptosis after
treatment with these regimens in these patients.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two
treatment arms.

Arm I: Patients receive docetaxel IV over 30 minutes once weekly for 3 weeks. Arm II:
Patients receive oral thalidomide daily beginning on day 2 and docetaxel IV over 30 minutes
on days 2, 9, and 16.

Treatment continues every 28 days in both arms in the absence of unacceptable toxicity or
disease progression.

Patients are followed every 2 months.


A total of 75 patients (25 to arm I and 50 to arm II) will be accrued for this study within
18 months.

Inclusion Criteria


--Disease Characteristics-- Histologically confirmed androgen-independent metastatic
adenocarcinoma of the prostate Clinically progressive disease documented by at least 1 of
the following: Two consecutively rising PSA levels (PSA at least 5.0) At least 1 new
lesion on bone scan Progressive measurable disease If no prior surgical castration, serum
testosterone must be less than 50 ng/mL and continue on gonadotropin-releasing hormone If
receiving an antiandrogen and PSA level rising, must demonstrate a continued rise in PSA 4
weeks after stopping flutamide and 6 weeks after stopping bicalutamide or nilutamide No
brain metastases --Prior/Concurrent Therapy-- Biologic therapy: No prior thalidomide
Chemotherapy: No prior chemotherapy for metastatic prostate cancer No prior docetaxel
Endocrine therapy: See Disease Characteristics Radiotherapy: Recovered from prior
radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery --Patient
Characteristics-- Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin less than 1.0 mg/dL AST/ALT less than 2.5 times
upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN Renal: Creatinine
no greater than 1.5 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No
history of myocardial infarction within past 6 months No uncontrolled congestive heart
failure or angina pectoris Other: No other prior active malignancy within the past 2 years
except nonmelanoma skin cancer or carcinoma in situ of the bladder Fertile patients must
use effective contraception at least 1 month prior to, during, and for 1 month after study

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

William Dahut

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

September 2003

Related Keywords:

  • Stage IV Prostate Cancer
  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • adenocarcinoma of the prostate
  • adult solid tumor
  • body system/site cancer
  • cancer
  • cellular diagnosis, prostate cancer
  • genetic condition
  • male reproductive cancer
  • prostate cancer
  • recurrent prostate cancer
  • solid tumor
  • stage IV prostate cancer
  • stage, prostate cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Medicine Branch Bethesda, Maryland  20892