Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
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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 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer |
- 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 ]
- 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 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
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 |
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| United States, Connecticut | |
| Whittingham Cancer Center at Norwalk Hospital | |
| Norwalk, Connecticut, United States, 06856 | |
| Carl and Dorothy Bennett Cancer Center at Stamford Hospital | |
| Stamford, Connecticut, United States, 06904 | |
| Study Chair: | Richard C. Frank, MD | Whittingham Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00046826 History of Changes |
| Other Study ID Numbers: | CDR0000069081, NH-0139, NCI-V01-1681 |
| Study First Received: | October 3, 2002 |
| Last Updated: | April 2, 2013 |
| 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:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Estramustine Docetaxel Thalidomide Sodium phosphate Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Cathartics Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013