PRIMARY OBJECTIVES:
I. To determine the maximally tolerated dose (MTD-malignant melanoma [MM]) of Abraxane (nab-paclitaxel)/bevacizumab-complex (AB-complex) among patients with metastatic malignant melanoma.
II. To determine the maximally tolerated dose (MTD-gynecologic [GYN]) of AB-complex among patients with gynecologic cancers.
III. To further assess the safety profile and anti-tumor activity of the recommended phase II dose of AB-complex for patients with previously-treated endometrial cancer IV. To further assess the safety profile and anti-tumor activity of the recommended phase II dose of AB-complex for patients with previously treated ovarian cancer
SECONDARY OBJECTIVES:
I. To gather preliminary data on tumor response rate and progression free survival time of AB-complex among patients with metastatic malignant melanoma.
II. To gather preliminary data on tumor response rate and progression free survival time of AB-complex among patients with gynecologic cancers.
CORRELATIVE OBJECTIVES (DOSE-ESCALATION COHORTS ONLY):
I. Pharmacokinetics of paclitaxel administered in the context of AB-complex. II. Tumor concentrations of paclitaxel 24 hour (h) following AB-complex infusion and correlation with plasma levels.
OUTLINE: This is a dose-escalation study.
Patients receive nab-paclitaxel/bevacizumab-complex intravenously (IV) over 30-60 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may receive paclitaxel if supply of nab-paclitaxel is exhausted.
After completion of study treatment, patients are followed up every 6 months for 12 months.
Source: View full study details on ClinicalTrials.gov
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