Full Text View
Tabular View
No Study Results Posted
Related Studies
Ixabepilone and Liposomal Doxorubicin in Treating Women With Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer or Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
First Received: September 15, 2005   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00182767
  Purpose

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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Ovarian Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Ixabepilone
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2005
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose and recommended phase II dose of ixabepilone when combined with pegylated doxorubicin HCl liposome in women with previously treated advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer.
  • Determine the safety profile of this regimen in these patients.
  • Determine the clinical efficacy of this regimen in patients with platinum- and taxane-resistant advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.

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.

  • Phase I (closed to accrual as of 12/6/07): Patients receive ixabepilone IV over 3 hours and pegylated doxorubicin HCl liposome IV over 30-60 minutes on day 1. Courses repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 4 additional courses beyond CR. Patients receive a maximum cumulative doxorubicin dose of 500 mg/m^2 (including prior doxorubicin and pegylated doxorubicin HCl liposome). Patients with responding disease may continue to receive ixabepilone alone at the discretion of the treating physician.

Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive ixabepilone (at the MTD determined in phase I) and pegylated doxorubicin HCl liposome as in phase I (closed to accrual as of 12/6/07). After completion of study treatment, patients are followed for up to 2 years.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed diagnosis of 1 of the following:

    • Advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer (phase I [closed to accrual as of 12/6/07] and II)
    • Metastatic breast cancer (phase I only [closed to accrual as of 12/6/07])
  • Measurable or evaluable disease, meeting 1 of the following criteria:

    • Unidimensionally measurable lesion
    • Known disease AND CA 125 > 50 U/mL on 2 occasions ≥ 1 week apart
    • Known disease AND CA 27-29, CA 15-3, or CA 125 > 50 U/mL on 2 occasions ≥ 1 week apart (for breast cancer patients)
  • 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

      • Platinum-refractory or -sensitive disease (phase I [closed to accrual as of 12/6/07])
      • Platinum- and taxane-resistant disease, defined as a disease-free interval of < 6 months after completion of platinum- and taxane-based chemotherapy OR disease progression during the regimen (phase II)
    • Previously treated with ≥ 2 prior regimens for metastatic breast cancer, including 1 taxane-based regimen in the adjuvant or metastatic setting (phase I [closed to accrual as of 12/6/07])
  • No active brain metastases, including any of the following:

    • Evidence of cerebral edema by CT scan or MRI
    • Evidence of disease progression on prior imaging studies
    • Requirement for steroids
    • Clinical symptoms of brain metastasis
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)

Renal

  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to Cremophor® or study drugs
  • No neuropathy ≥ grade 2
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • At least 1 week since prior chemotherapy if given on a daily or weekly schedule and recovered
  • No prior doxorubicin HCl liposome

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • At least 3 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • Recovered for more than 4 weeks from all adverse events related to prior agents
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182767

Locations
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    
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Ellen Chuang, MD Weill Medical College of Cornell University
  More Information

Additional Information:
Publications:
Chuang E, Vahdat L, Caputo T, et al.: Phase I clinical trial of ixabepilone and pegylated liposomal doxorubicin in patients with advanced breast or ovarian cancers: New York Cancer Consortium trial P7229. [Abstract] J Clin Oncol 25 (Suppl 18): A-2570, 2007.

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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
Fallopian Tube Diseases
Digestive System Diseases
Tubulin Modulators
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Endocrinopathy

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009