Ixabepilone With or Without Estramustine in Treating Patients With Progressive Prostate Cancer

NCT00025194 | Completed Phase 1

• 4 other identifiers: CDR0000068935MSKCC-01064MSKCC-01064ANCI-3634
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ixabepilone and estramustine, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether BMS-247550 is more effective with or without estramustine in treating prostate cancer. PURPOSE: This randomized phase I/II trial is studying the best dose of ixabepilone when given together with estramustine and to see how well giving ixabepilone together with estramustine works compared to ixabepilone alone in treating patients with progressive prostate cancer.

Conditions

Prostate Cancer

Keywords

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

Interventions

estramustine phosphate sodium DRUG

ixabepilone DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Must have disease progression meeting 1 of the following criteria: * Rising prostate-specific antigen (PSA) on at least 3 consecutive measurements taken more than 1 week apart * Measurable disease, defined as new or progressive soft tissue masses on CT scan or MRI * New metastatic lesions by radionuclide bone scan * The most recent PSA must be at least 4 ng/mL if no measurable disease is present * Ineligible if sole manifestation of progressive disease is an increase in disease-related symptoms * Serum testosterone no greater than 50 ng/mL * One of the following therapies for maintenance of castrate status required: * Must continue on gonadotropin-releasing hormone analogs (e.g., leuprolide or goserelin) to maintain castrate levels of serum testosterone * Developed disease progression after discontinuation of the antiandrogen that was part of the first-line hormonal therapy * Prior surgical orchiectomy * Developed disease progression after discontinuation of megestrol * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No history of bleeding disorder that would preclude anticoagulation with warfarin Hepatic: * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal (ULN) * PT/PTT normal (unless anticoagulated for other reasons \[e.g., atrial fibrillation\]) Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No significant cardiovascular disease * No symptomatic congestive heart failure * No New York Heart Association class III or IV heart disease * No active unstable angina pectoris * No cardiac arrhythmia * No myocardial infarction within the past 6 months * No history of hemorrhagic or thrombotic cerebrovascular accident or deep venous thrombosis within the past 6 months Pulmonary: * No pulmonary embolism within the past 6 months Other: * Fertile patients must use effective contraception * No history of allergic reactions to compounds of similar chemical or biological composition to the epothilones * No history of recent gastrointestinal bleeding that would preclude anticoagulation with warfarin * No other concurrent active malignancy except nonmelanomatous skin cancer * Disease not considered currently active if completely treated with less than a 30% risk for relapse * No other concurrent uncontrolled illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF) except for neutropenic fever * No concurrent immunotherapy Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * See Disease Characteristics Radiotherapy: * No prior palliative radiotherapy to more than 25% of bone marrow * No prior radioisotope therapy with strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium * No concurrent therapeutic radiotherapy * Concurrent focal radiotherapy for palliation of bone disease-related symptoms allowed at the investigator's discretion Surgery: * See Disease Characteristics * At least 4 weeks since prior major surgery Other: * No other concurrent anticancer investigational or commercial agents or therapies * No concurrent herbal, alternative, or food supplements (e.g., PC-SPES, saw palmetto, or St. John's Wort) * No concurrent combination antiretroviral therapy for HIV-positive patients * No initiation of bisphosphonates immediately before or during study * Concurrent bisphosphonates allowed if developed disease progression while on stable doses * Concurrent daily multivitamin allowed

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (3)

• Galsky MD, Small EJ, Oh WK, Chen I, Smith DC, Colevas AD, Martone L, Curley T, Delacruz A, Scher HI, Kelly WK. Multi-institutional randomized phase II trial of the epothilone B analog ixabepilone (BMS-247550) with or without estramustine phosphate in patients with progressive castrate metastatic prostate cancer. J Clin Oncol. 2005 Mar 1;23(7):1439-46. doi: 10.1200/JCO.2005.09.042.

  PMID: 15735119 RESULT

• Smaletz O, Galsky M, Scher HI, DeLaCruz A, Slovin SF, Morris MJ, Solit DB, Davar U, Schwartz L, Kelly WK. Pilot study of epothilone B analog (BMS-247550) and estramustine phosphate in patients with progressive metastatic prostate cancer following castration. Ann Oncol. 2003 Oct;14(10):1518-24. doi: 10.1093/annonc/mdg415.

  PMID: 14504052 RESULT

• Smaletz O, Kelly WK, Horse-Grant D, et al.: Epothilone B analogue (BMS-247550) with estramustine phosphate (EMP) in patients (pts) with progressive castrate-metastatic prostate cancer (PC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-732, 184a, 2002.

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Estramustine; ixabepilone

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

Study Officials

• Michael Morris, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Study Completion: July 1, 2006
• Last Updated: June 24, 2013

Record last verified: 2005-11

Locations

US (4)