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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
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

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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)

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Ellen Chuang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00140

NCT ID:

NCT00182767

Start Date:

January 2006

Completion Date:

Related Keywords:

  • 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
  • Breast Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

Montefiore Medical CenterBronx, New York  10467-2490