Status:
WITHDRAWN
Paclitaxel, Topotecan, and Estramustine in Treating Patients With Metastatic Hormone-Refractory Prostate Cancer
Lead Sponsor:
Fox Chase Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemo...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel, topotecan, and estramustine. * Determine the progr...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate gland
- Progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases)
- Radiologic evidence of hydronephrosis alone dose not constitute metastatic disease
- Failed prior primary hormonal therapy (e.g., estrogen therapy, luteinizing hormone-releasing hormone blocker and flutamide) or bilateral orchiectomy
- Patients previously treated with flutamide or bicalutamide must have evidence of disease progression i.e., increasing Prostate-Specific Antigen (PSA)
- PSA level ≥ 10 ng/mL if bone metastases only are present (i.e., lacking measurable soft tissue disease)
- No elevated serum acid phosphatase or PSA level as the only evidence of disease
- No carcinomatous meningitis or brain metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectancy
- At least 12 weeks
- Hematopoietic
- White Blood Cell (WBC) ≥ 4,000/mm\^3 OR
- Granulocyte count ≥ 2,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Serum Glutamic-Oxaloacetic Transaminase(SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2 times normal
- Bilirubin ≤ 1.5 mg/dL
- Renal
- Creatinine ≤ 2.0 mg/dL OR
- Creatinine clearance ≥ 50 mL/min
- Cardiovascular
- History of deep venous thrombosis allowed provided patients are maintained on therapeutic anticoagulation therapy
- No active angina pectoris
- No New York Heart Association class II-IV heart disease
- No myocardial infarction within the past 6 months
- No thrombosis within the past 3 months
- Other
- Fertile patients must use effective contraception during and for 3 months after study participation
- No active infection
- No other concurrent serious medical illness that would preclude study participation
- No other malignancy within the past 3 years except curatively treated basal cell or squamous cell skin cancer
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy
- Endocrine therapy
- See Disease Characteristics
- At least 4 weeks since prior flutamide
- At least 8 weeks since prior bicalutamide
- Radiotherapy
- More than 4 weeks since prior radiotherapy
- No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
- Surgery
- See Disease Characteristics
- Other
- Recovered from all prior therapy
- No prior cytotoxic therapy for prostate cancer
- No concurrent milk, milk products, antacids, calcium-containing drugs, or food during estramustine administration
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00084565
Start Date
November 1 2003
End Date
November 1 2004
Last Update
July 10 2013
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