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A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer


OBJECTIVES:

Primary

- Determine the prostate-specific antigen response in patients with androgen-independent
metastatic adenocarcinoma of the prostate treated with docetaxel, estramustine, and
thalidomide.

Secondary

- Determine the survival duration in patients treated with this regimen.

- Determine the pharmacokinetics of both docetaxel and thalidomide in patients treated
with this regimen.

- Determine whether any pharmacodynamic relationships exist between plasma concentrations
of docetaxel and/or thalidomide and clinical activity or toxicity of this regimen in
these patients.

- Determine the existence of and quantification of circulating prostate cancer cells in
patients before and after treatment with this regimen.

- Determine genotype, with regard to cytochrome P450 2C19 polymorphism, in patients
treated with this regimen.

- Correlate genotype with pharmacokinetics and efficacy of this regimen in these
patients.

- Determine the changes in molecular markers of angiogenesis (including, but not limited
to, serum and urine vascular endothelial growth factor) in patients before and after
treatment with this regimen.

- Determine the toxicity profile of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive docetaxel IV over 30 minutes on days 2, 9, and 16, oral thalidomide once
daily on days 1-28, and oral estramustine three times daily on days 1-3, 8-10, and 15-17.
Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 33-60 patients will be accrued for this study within 11-20
months.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA response

Safety Issue:

No

Principal Investigator

Avi S. Retter, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Eastchester Center for Cancer Care

Authority:

United States: Federal Government

Study ID:

040132

NCT ID:

NCT00083005

Start Date:

March 2004

Completion Date:

December 2007

Related Keywords:

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

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182
NCI - Center for Cancer ResearchBethesda, Maryland  20892