Paclitaxel, Topotecan, and Estramustine in Treating Patients With Metastatic Hormone-Refractory Prostate Cancer

NCT00084565 | Withdrawn Phase 2

• 2 other identifiers: FCCC-03035CDR0000365459
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel, topotecan, and estramustine together works in treating patients with metastatic hormone therapy-refractory prostate cancer.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; adenocarcinoma of the prostate

Interventions

estramustine phosphate sodium DRUG

paclitaxel DRUG

topotecan hydrochloride 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 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

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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Estramustine; Paclitaxel; Topotecan

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)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Gary R. Hudes, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: November 1, 2003
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: July 10, 2013

Record last verified: 2013-07