Ixabepilone and Liposomal Doxorubicin in Advanced Ovarian Cancer

NCT ID: NCT00182767

Last Updated: 2016-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2014-05-31

Brief Summary

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.

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.

Conditions

Fallopian Tube Cancer; Female Reproductive Cancer; Recurrent Breast Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Breast Cancer; Stage IV Ovarian Epithelial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (ixabepilone and doxorubicin)

Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.

Group Type: EXPERIMENTAL

ixabepilone

Intervention Type: DRUG

Given IV

pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

Given IV

Interventions

ixabepilone

Given IV

Intervention Type: DRUG

pegylated liposomal doxorubicin hydrochloride

Given IV

Intervention Type: DRUG

Other Intervention Names

BMS-247550; epothilone B lactam; Ixempra; CAELYX; Dox-SL; DOXIL; doxorubicin hydrochloride liposome; LipoDox

Eligibility Criteria

Inclusion Criteria

• 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).
• 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 );
• 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%
• 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.
• At least 3 weeks since prior radiotherapy and recovered.
• Recovered for more than 4 weeks from all adverse events related to prior agents.
• Normal organ function including:
• Normal bilirubin
• 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

Exclusion Criteria

• 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.
• Life expectancy of more than 3 months
• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen Chuang

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center - Moses Campus

Locations

University of Connecticut

Farmington, Connecticut, United States

Women's Cancer Care Associates LLC

Albany, New York, United States

Weill Medical College of Cornell University

New York, New York, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Countries

United States

References

Chuang E, Wiener N, Christos P, Kessler R, Cobham M, Donovan D, Goldberg GL, Caputo T, Doyle A, Vahdat L, Sparano JA. Phase I trial of ixabepilone plus pegylated liposomal doxorubicin in patients with adenocarcinoma of breast or ovary. Ann Oncol. 2010 Oct;21(10):2075-2080. doi: 10.1093/annonc/mdq080. Epub 2010 Mar 31.

Reference Type: RESULT

PMID: 20357034 (View on PubMed)

Other Identifiers

NCI-2009-00140

Identifier Type: OTHER

Identifier Source: secondary_id

0504007857

Identifier Type: OTHER

Identifier Source: secondary_id

7229

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM62204

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA013330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00140

Identifier Type: -

Identifier Source: org_study_id