Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Suspended
- Estimated Enrollment
- 18
Summary
- Conditions
- Cervical Adenosarcoma
- Cervical Adenocarcinoma
- Malignant Peritoneal Neoplasm
- Fallopian Tube Transitional Cell Carcinoma
- Malignant Ovarian Endometrioid Tumor
- Cervical Adenosquamous Carcinoma
- Cervical Carcinosarcoma
- Malignant Ovarian Epithelial Tumor
- Primary Peritoneal Clear Cell Adenocarcinoma
- Fallopian Tube Clear Cell Adenocarcinoma
- Ovarian Endometrioid Adenocarcinoma
- Ovarian Carcinosarcoma
- Ovarian Clear Cell Adenocarcinoma
- Platinum-Resistant Ovarian Carcinoma
- Primary Peritoneal Carcinosarcoma
- Unresectable Melanoma
- Ovarian Transitional Cell Carcinoma
- Platinum-Resistant Primary Peritoneal Carcinoma
- Primary Peritoneal Serous Adenocarcinoma
- Cervical Squamous Cell Carcinoma, Not Otherwise Specified
- Malignant Ovarian Clear Cell Tumor
- Platinum-Sensitive Ovarian Carcinoma
- Uterine Corpus Carcinosarcoma
- Malignant Ovarian Mucinous Tumor
- Fallopian Tube Serous Adenocarcinoma
- Endometrial Adenosquamous Carcinoma
- Endometrial Clear Cell Adenocarcinoma
- Fallopian Tube Endometrioid Adenocarcinoma
- Endometrial Endometrioid Adenocarcinoma
- Ovarian Mucinous Adenocarcinoma
- Fallopian Tube Adenocarcinoma
- Ovarian Undifferentiated Carcinoma
- Stage IV Cutaneous Melanoma AJCC v6 and v7
- Fallopian Tube Squamous Cell Carcinoma
- Endometrial Mixed Cell Adenocarcinoma
- Platinum-Resistant Fallopian Tube Carcinoma
- Primary Peritoneal Transitional Cell Carcinoma
- High Grade Ovarian Serous Adenocarcinoma
- Malignant Solid Neoplasm
- Ovarian Serous Adenocarcinoma
- Primary Peritoneal Undifferentiated Carcinoma
- Fallopian Tube Carcinosarcoma
- Fallopian Tube Undifferentiated Carcinoma
- Endometrial Undifferentiated Carcinoma
- Endometrial Mucinous Adenocarcinoma
- Endometrial Serous Adenocarcinoma
- Fallopian Tube Mucinous Adenocarcinoma
- Malignant Female Reproductive System Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 pa...
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. After completion of study treatment, patients are followed up every 6 months for 12 months.
Tracking Information
- NCT #
- NCT02020707
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Matthew S Block Mayo Clinic in Rochester
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