Trial | NCT00046826  Report issue

Title

Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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.
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.
Study Started
Sep 30
2001
Primary Completion
Jun 30
2007
Study Completion
Oct 31
2009
Last Update
Apr 04
2013
Estimate

Drug docetaxel

Drug estramustine phosphate sodium

Drug thalidomide

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
No Results Posted