A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
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 Office | Bethesda, Maryland 20892-1182 |
| NCI - Center for Cancer Research | Bethesda, Maryland 20892 |
