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Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel
estramustine phosphate sodium
thalidomide
Sponsored by
Nuvance Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Whittingham Cancer Center at Norwalk Hospital
  • Carl and Dorothy Bennett Cancer Center at Stamford Hospital

Outcomes

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

Secondary Outcome Measures

Safety and toxicity as measured by CTC toxicity grading at baseline and during every visit
Effectiveness of taxotere, emcyt, and thalidomide in pain control as measured by the pain scale at baseline and during every visit

Full Information

First Posted
October 3, 2002
Last Updated
April 2, 2013
Sponsor
Nuvance Health
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1. Study Identification

Unique Protocol Identification Number
NCT00046826
Brief Title
Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
Official Title
A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nuvance Health

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
estramustine phosphate sodium
Intervention Type
Drug
Intervention Name(s)
thalidomide
Primary Outcome Measure Information:
Title
Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment
Secondary Outcome Measure Information:
Title
Safety and toxicity as measured by CTC toxicity grading at baseline and during every visit
Title
Effectiveness of taxotere, emcyt, and thalidomide in pain control as measured by the pain scale at baseline and during every visit

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard C. Frank, MD
Organizational Affiliation
Nuvance Health
Official's Role
Study Chair
Facility Information:
Facility Name
Whittingham Cancer Center at Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Carl and Dorothy Bennett Cancer Center at Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy

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