A Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab for Breast Cancer

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer. The study will also assess the safety of this combination treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R-Pharm
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Epothilones; Paclitaxel

Criteria

Inclusion criteria:

• Locally recurrent or metastatic breast cancer, previously untreated with chemotherapy for advanced disease.

• At least 1 target lesion per RECIST criteria. Locally recurrent disease must not be amenable to resection with curative intent.

• No previous cytotoxic chemotherapy for locally recurrent/metastatic disease.

• Relapse 12 months or more after completing prior adjuvant or neoadjuvant taxane therapy.

• No previous breast cancer known to overexpress or amplify the human epidermal growth factor receptor 2 gene.

• Prior hormonal therapy in adjuvant, recurrent, or metastatic setting allowed but must have been discontinued at least 2 weeks before randomization.

• Karnofsky performance status of 80 to 100 or Eastern Cooperative Oncology Group performance status of 0 to 1.

• Estimated life expectancy of at least 12 weeks.

• Recovery from recent therapy (except for alopecia), including chemotherapy, immunotherapy, biologic therapy, or investigational product. Any such therapy must have been completed at least 3 weeks before randomization and at least 6 weeks from use of nitrosourea, or mitomycin.

• Recovery from recent surgery and radiation therapy. At least 1 week since minor surgery and/or focal/palliative radiation therapy; at least 3 weeks from radiation; at least 4 weeks from major surgery; and at least 8 weeks from liver resection, thoracotomy, or neurosurgery.

• Absolute neutrophil count ≥1500/mm^3.

• Hemoglobin ≥9 g/dL.

• Platelets ≥100,000/mm^3.

• Total bilirubin ≤1.5 times the upper limit of normal (ULN).

• Aspartate aminotransferase or alanine aminotransferase ≤2.5*ULN.

• Normal partial thromboplastin time and either international normalized ratio or prothrombin time <1.5*ULN.

• Serum creatinine ≤1.5*ULN or 24-hour creatinine clearance >60 mL/min.

• Urine dipstick for proteinuria <2+ (negative, trace, or +1). Participants with ≥2+ proteinuria at baseline were to undergo 24-hour urine collection and demonstrate ≤1g of protein in 24 hours to be eligible.

Exclusion criteria:

• Women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 6 months after treatment with bevacizumab.

• Women who were pregnant or breastfeeding.

• Women with a positive pregnancy test on enrollment or prior to study drug administration.

• Sexually active fertile men, whose partners were WOCBP, not using an adequate method of birth control.

• Evidence of baseline sensory or motor neuropathy.

• Serious infection or nonmalignant medical illnesses uncontrolled or the control of which could be jeopardized by this therapy.

• History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious gastric ulcer, or bone fracture within 6 months of study entry.

• History of hypertensive crisis or hypertensive encephalopathy.

• Significant vascular disease.

• Clinically significant cardiovascular disease.

• Baseline left ventricular ejection fraction by multiple-gated acquisition scan or echocardiogram for subjects with prior exposure to anthracyclines not within institutional normal limits.

• Symptomatic peripheral vascular disease.

• History of high dose chemotherapy with bone marrow transplant or peripheral blood stem cell transplant within the previous 2 years.

• Evidence of bleeding diathesis or coagulopathy.

• Prior treatment with an epothilone or any antiangiogenic agent.

• Concurrent nonhealing wound, ulcer, or fracture.

• Any current or history of brain and/or leptomeningeal metastases. Psychiatric disorders or other conditions rendering the participant incapable of complying with the requirements of the protocol.

• Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix.

• Known allergy to any of the study drugs or their excipients.