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

NCT00046826 | Completed Phase 2

• 3 other identifiers: CDR0000069081NH-0139NCI-V01-1681
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment

Secondary Outcomes (2)

• 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

Interventions

docetaxel DRUG

estramustine phosphate sodium DRUG

thalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nuvance Health: lead

Study Sites (2)

Whittingham Cancer Center at Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Carl and Dorothy Bennett Cancer Center at Stamford Hospital

Stamford, Connecticut, 06904, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Estramustine; Thalidomide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Richard C. Frank, MD

  Nuvance Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2001
• Primary Completion: June 1, 2007
• Study Completion: October 1, 2009
• Last Updated: April 4, 2013

Record last verified: 2006-01

Locations

US (2)