Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy - Full Text View

Sponsor:	Whittingham Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00046826

Purpose

RATIONALE: Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with thalidomide may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and estramustine with thalidomide in treating patients who have prostate cancer previously treated with hormone therapy.

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 Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory 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:

Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and toxicity as measured by CTC toxicity grading at baseline and during every visit [ Designated as safety issue: Yes ]
Effectiveness of taxotere, emcyt, and thalidomide in pain control as measured by the pain scale at baseline and during every visit [ Designated as safety issue: No ]

Study Start Date:	September 2001
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the objective response rate in patients with hormone-refractory prostate cancer treated with docetaxel, estramustine, and thalidomide.
Determine the safety and toxicity of this regimen in these patients.
Determine the efficacy of this regimen for pain control in these patients.

OUTLINE: Patients receive oral estramustine on days 1-3 and docetaxel IV over 1 hour on day 2 for 3 weeks. Treatment repeats every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients also receive oral thalidomide once daily beginning on day 1 and continuing for 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly until disease progression.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.

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
Prior treatment with androgen ablation including:
- Orchiectomy OR
- Luteinizing hormone-releasing hormone (LHRH) therapy (e.g., leuprolide)
  - Patients on leuprolide must continue to receive the drug
Prior nonsteroidal antiandrogens (e.g., flutamide, bicalutamide, or nilutamide) required
Metastatic disease with disease progression during androgen ablation, defined by at least 1 of the following:
- 2 consecutive increased prostate-specific antigen (PSA) levels measured at least 1 week apart
- More than 25% increase in bidimensionally measurable soft tissue metastases
- 20% increase in the sum of the baseline sum of longest diameter of measurable lesions
- Appearance of new lesions
- Appearance of new foci on a radionuclide bone scan
PSA greater than 10 ng/dL
Testosterone no greater than 50 ng/mL (castrate level)
No CNS metastases

PATIENT CHARACTERISTICS:

Age:

Over 18

Performance status:

Karnofsky 70-100%

Life expectancy:

More than 16 weeks

Hematopoietic:

WBC greater than 3,500/mm3
Absolute neutrophil count greater than 1,500/mm3
Platelet count greater than 100,000/mm3
Hemoglobin at least 8 g/dL

Hepatic:

AST and/or ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR
Alkaline phosphatase no greater than 4 times ULN if AST/ALT no greater than ULN
Bilirubin no greater than ULN

Renal:

Creatinine less than 2.2 mg/dL

Cardiovascular:

No myocardial infarction within the past 6 months
No New York Heart Association class III or IV heart disease
No history of arterial or venous thrombosis
No cerebrovascular accident within the past year

Pulmonary:

No history of pulmonary embolism

Other:

Fertile patients must use effective contraception during and for 4 weeks after study
No peripheral neuropathy grade 2 or greater
No active infection
No serious concurrent medical illness that would preclude study
No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
No other prior or concurrent active malignancy within the past 2 years except non-melanoma skin cancers
No other medical condition or reason that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for prostate cancer

Endocrine therapy:

See Disease Characteristics
At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and continued evidence of disease progression (rising PSA)
Prior steroids for prostate cancer allowed
No concurrent steroids except for pre-medication for docetaxel

Radiotherapy:

At least 4 weeks since prior radiotherapy

Surgery:

See Disease Characteristics

Other:

No concurrent herbal supplements to treat prostate cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046826

Locations

United States, Connecticut
Carl and Dorothy Bennett Cancer Center at Stamford Hospital
Stamford, Connecticut, United States, 06904
Whittingham Cancer Center at Norwalk Hospital
Norwalk, Connecticut, United States, 06856

Sponsors and Collaborators

Whittingham Cancer Center

Investigators

Study Chair:

Richard C. Frank, MD

Whittingham Cancer Center

More Information

Additional Information:

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

Publications:

Frank RC, Coscia A, Versea L, et al.: Low dose docetaxel, estramustine and thalidomide followed by maintenance thalidomide for the treatment of hormone refractory prostate cancer (HRPC): a phase II community based trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-4681, 426s, 2004.

Study ID Numbers:	CDR0000069081, NH-0139, NCI-V01-1681
Study First Received:	October 3, 2002
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00046826 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:

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

Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents
Antineoplastic Agents, Hormonal
Growth Substances
Genital Diseases, Male
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Antineoplastic Agents, Alkylating
Prostatic Neoplasms
Leprostatic Agents

ClinicalTrials.gov processed this record on November 09, 2009