Ixabepilone and Liposomal Doxorubicin in Treating Women With Advanced Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00182767
First received: September 15, 2005
Last updated: August 4, 2014
Last verified: February 2014
  Purpose

This trial is studying the side effects and best dose of ixabepilone when given together with pegylated liposomal doxorubicin hydrochloride 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. Drugs used in chemotherapy, such as ixabepilone and pegylated liposomal doxorubicin hydrochloride, 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.


Condition Intervention Phase
Fallopian Tube Cancer
Female Reproductive Cancer
Primary Peritoneal Cavity Cancer
Recurrent Breast Cancer
Recurrent Ovarian Epithelial Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Breast Cancer
Stage IV Ovarian Epithelial Cancer
Drug: ixabepilone
Drug: pegylated liposomal doxorubicin hydrochloride
Other: pharmacological study
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) of ixabepilone, determined according to incidence of dose-limiting toxicity (DLT), graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4.0 (Phase I) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients responding to therapy (complete response [CR], partial response [PR], or stable disease [SD]), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) and cancer antigen-125 (CA-125) response criteria (Phase II) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: The time from start of treatment to time of progression or death, assessed up to 2 years ] [ Designated as safety issue: No ]
    We will summarize progression-free survival by Kaplan-Meier survival analysis.


Enrollment: 46
Study Start Date: January 2006
Study Completion Date: May 2014
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (ixabepilone and doxorubicin hydrochloride)
Patients receive ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra
Drug: pegylated liposomal doxorubicin hydrochloride
Given IV
Other Names:
  • CAELYX
  • Dox-SL
  • DOXIL
  • doxorubicin hydrochloride liposome
  • LipoDox
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose and recommended phase II dose of ixabepilone when combined with pegylated doxorubicin hydrochloride (HCl) liposome (pegylated liposomal doxorubicin hydrochloride) in women with previously treated advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer.

II. To determine the safety profile of this regimen in these patients. III. To 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, multicenter, open-label, dose-escalation study of ixabepilone followed by a phase II study.

Patients receive ixabepilone intravenously (IV) over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. Courses repeat every 21-28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 2 years.

  Eligibility

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

Criteria:

  • 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.
  • At least 3 weeks since prior radiotherapy and recovered.
  • 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.
  • Has received a previous chemotherapy regimen for this cancer that included drugs such as docetaxel or paclitaxel.
  • Histologically or cytologically confirmed diagnosis of 1 of the following: advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer (phase I and II) or metastatic breast cancer (phase I only).
  • 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 or 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)

  • ECOG 0-2 or Karnofsky 60-100%
  • Life expectancy of more than 3 months
  • Bilirubin normal
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • 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.
  • WBC >= 3,000/mm3
  • Absolute neutrophil count >= 1,500/mm3
  • Platelet count >= 100,000/mm3
  • AST and ALT =< 2.5 times upper limit of normal (ULN)
  • Creatinine =< 1.5 times ULN or Creatinine clearance ≥ 60 mL/min
  • Platinum- and taxane-resistant disease, defined as a disease-free interval of < 6 months after completion of platinum- and taxane-based chemotherapy. Disease progression during the regimen (phase II) or previously treated with >= 2 prior regimens for metastatic breast cancer, including 1 taxane-based regimen in the adjuvant or metastatic setting (phase I).
  • 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, that is platinum-refractory or -sensitive disease (phase I );
  • 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 or clinical symptoms of brain metastasis.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00182767

Locations
United States, Connecticut
University of Connecticut
Farmington, Connecticut, United States, 06030
United States, New York
Women's Cancer Care Associates LLC
Albany, New York, United States, 12208
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
Weill Medical College of Cornell University
New York, New York, United States, 10065
Sponsors and Collaborators
Investigators
Principal Investigator: Ellen Chuang Montefiore Medical Center - Moses Campus
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00182767     History of Changes
Other Study ID Numbers: NCI-2009-00140, NCI-2009-00140, 0504007857, CDR0000441122, 0504007857, 7229, N01CM62204, P30CA013330
Study First Received: September 15, 2005
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Breast Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Breast Diseases
Skin Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014