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 Adenocarcinoma
- Cervical Adenosarcoma
- Cervical Adenosquamous Carcinoma
- Cervical Carcinosarcoma
- Malignant Solid Neoplasm
- Cervical Squamous Cell Carcinoma, Not Otherwise Specified
- Endometrial Adenosquamous Carcinoma
- High Grade Ovarian Serous Adenocarcinoma
- Endometrial Undifferentiated Carcinoma
- Malignant Ovarian Mucinous Tumor
- Ovarian Clear Cell Adenocarcinoma
- Primary Peritoneal Undifferentiated Carcinoma
- Uterine Corpus Carcinosarcoma
- Endometrial Clear Cell Adenocarcinoma
- Ovarian Transitional Cell Carcinoma
- Ovarian Undifferentiated Carcinoma
- Fallopian Tube Squamous Cell Carcinoma
- Malignant Female Reproductive System Neoplasm
- Primary Peritoneal Serous Adenocarcinoma
- Platinum-Resistant Primary Peritoneal Carcinoma
- Fallopian Tube Adenocarcinoma
- Fallopian Tube Carcinosarcoma
- Ovarian Mucinous Adenocarcinoma
- Primary Peritoneal Transitional Cell Carcinoma
- Fallopian Tube Serous Adenocarcinoma
- Stage IV Cutaneous Melanoma AJCC v6 and v7
- Platinum-Resistant Ovarian Carcinoma
- Malignant Peritoneal Neoplasm
- Endometrial Endometrioid Adenocarcinoma
- Fallopian Tube Endometrioid Adenocarcinoma
- Ovarian Carcinosarcoma
- Unresectable Melanoma
- Platinum-Resistant Fallopian Tube Carcinoma
- Platinum-Sensitive Ovarian Carcinoma
- Fallopian Tube Transitional Cell Carcinoma
- Primary Peritoneal Carcinosarcoma
- Endometrial Mixed Cell Adenocarcinoma
- Endometrial Mucinous Adenocarcinoma
- Malignant Ovarian Epithelial Tumor
- Ovarian Serous Adenocarcinoma
- Ovarian Endometrioid Adenocarcinoma
- Fallopian Tube Undifferentiated Carcinoma
- Malignant Ovarian Clear Cell Tumor
- Malignant Ovarian Endometrioid Tumor
- Primary Peritoneal Clear Cell Adenocarcinoma
- Endometrial Serous Adenocarcinoma
- Fallopian Tube Mucinous Adenocarcinoma
- Fallopian Tube Clear Cell Adenocarcinoma
- 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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