Docetaxel With or Without Thalidomide in Treating Patients With Metastatic Prostate Cancer

Original Study ID : CDR0000067602

Secondary ID : NCI-00-C-0033

NCT ID : NCT00020046

Brief Title : Docetaxel With or Without Thalidomide in Treating Patients With Metastatic Prostate Cancer

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

Brief Summary :

RATIONALE: Drugs used in chemotherapy use 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. PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel with or without thalidomide in treating patients who have metastatic prostate cancer.

Source : National Cancer Institute (NCI)

Detailed Description :

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

Overall Status : Completed

Start Date : December 1999

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment

Verification Date : June 2005

First Received Date : March 2, 2007

Trial Eligibility

Criteria :
PROTOCOL ENTRY 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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Facilities

Facility Name : Medicine Branch

City : Bethesda

State : Maryland

Zip Code : 20892

Country : United States

Interventions

Type : Drug

Name : docetaxel

Type : Drug

Name : thalidomide

Clinical Trial Name - Docetaxel With or Without Thalidomide in Treating Patients With Metastatic Prostate Cancer