Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00083005

Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel and estramustine, work in 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. Giving chemotherapy together with thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma (cancer) of the prostate.

Condition	Intervention	Phase
Prostate Cancer	Drug: docetaxel Drug: estramustine phosphate sodium Drug: thalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Thalidomide Estramustine phosphate sodium Docetaxel Estramustine Estramustine phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

PSA response [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Survival [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	March 2004
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083005

Locations

United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Avi S. Retter, MD

Eastchester Center for Cancer Care

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000361758, NCI-04-C-0132
Study First Received:	May 14, 2004
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00083005 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Prostatic Diseases
Genital Neoplasms, Male
Thalidomide
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Estramustine
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Hormones
Docetaxel
Anti-Bacterial Agents
Neoplasms by Site

Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Growth Substances
Genital Diseases, Male
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Antineoplastic Agents, Alkylating
Adenocarcinoma

ClinicalTrials.gov processed this record on November 27, 2009