Ixabepilone and Liposomal Doxorubicin in Advanced Ovarian Cancer
Fallopian Tube Cancer, Female Reproductive Cancer, Recurrent Breast Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer
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.
Sites / Locations
- University of Connecticut
- Women's Cancer Care Associates LLC
- Albert Einstein College of Medicine
- Montefiore Medical Center - Moses Campus
- Weill Medical College of Cornell University
Arms of the Study
Arm 1
Experimental
Treatment (ixabepilone and doxorubicin)
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.