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Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00182767 |
RATIONALE: Drugs used in chemotherapy, such as ixabepilone and liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone when given together with liposomal doxorubicin and to see how well they work in treating women with advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: ixabepilone Drug: pegylated liposomal doxorubicin hydrochloride |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study of BMS-247550 and Pegylated Liposomal Doxorubicin (Doxil®) in Patients With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer Who Have Been Previously Treated With a Platinum and a Taxane |
Estimated Enrollment: | 50 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a phase I (closed to accrual as of 12/6/07), multicenter, open-label, dose-escalation study of ixabepilone followed by a phase II study.
PROJECTED ACCRUAL: A total of 20-50 patients (3-18 for the phase I portion and 17-32 for the phase II portion) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Measurable or evaluable disease, meeting 1 of the following criteria:
Meets 1 of the following criteria:
Previously treated with a standard course of taxane- and platinum-based chemotherapy for ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer
No active brain metastases, including any of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Connecticut | |
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Recruiting |
Farmington, Connecticut, United States, 06030-1614 | |
Contact: Carolyn D. Runowicz, MD 860-679-4535 | |
United States, New York | |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
Bronx, New York, United States, 10461 | |
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
New York Weill Cornell Cancer Center at Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 | |
NYU Cancer Institute at New York University Medical Center | Recruiting |
New York, New York, United States, 10016 | |
Contact: Franco M. Muggia, MD 212-263-6485 muggif01@gcrc.med.nyu.edu |
Principal Investigator: | Ellen Chuang, MD | Weill Medical College of Cornell University |
Responsible Party: | Albert Einstein Cancer Center at Albert Einstein College of Medicine ( Joseph A. Sparano ) |
Study ID Numbers: | CDR0000441122, AECM-0504007857, NCI-7229 |
Study First Received: | September 15, 2005 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00182767 History of Changes |
Health Authority: | Unspecified |
fallopian tube cancer peritoneal cavity cancer recurrent ovarian epithelial cancer stage III ovarian epithelial cancer |
stage IV ovarian epithelial cancer stage IV breast cancer recurrent breast cancer |
Fallopian Tube Cancer Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Anti-Bacterial Agents Peritoneal Diseases Ovarian Cancer Taxane Breast Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Skin Diseases Epothilones |
Genital Neoplasms, Female Endocrine System Diseases Breast Neoplasms Antimitotic Agents Abdominal Neoplasms Ovarian Epithelial Cancer Recurrence Fallopian Tube Neoplasms Doxorubicin Digestive System Diseases Tubulin Modulators Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy |
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Urogenital Neoplasms Ovarian Diseases Antibiotics, Antineoplastic Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Breast Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Skin Diseases |
Epothilones Mitosis Modulators Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Antimitotic Agents Abdominal Neoplasms Pharmacologic Actions Fallopian Tube Neoplasms Doxorubicin Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Tubulin Modulators |