Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers
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|ClinicalTrials.gov Identifier: NCT02020707|
Recruitment Status : Suspended (Shortage of nab-paclitaxel (Abraxane))
First Posted : December 25, 2013
Last Update Posted : October 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cervical Adenocarcinoma Cervical Adenosarcoma Cervical Adenosquamous Carcinoma Cervical Carcinosarcoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Endometrioid Adenocarcinoma Endometrial Mixed Cell Adenocarcinoma Endometrial Mucinous Adenocarcinoma Endometrial Serous Adenocarcinoma Endometrial Undifferentiated Carcinoma Fallopian Tube Adenocarcinoma Fallopian Tube Carcinosarcoma Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube Mucinous Adenocarcinoma Fallopian Tube Serous Adenocarcinoma Fallopian Tube Squamous Cell Carcinoma Fallopian Tube Transitional Cell Carcinoma Fallopian Tube Undifferentiated Carcinoma High Grade Ovarian Serous Adenocarcinoma Malignant Female Reproductive System Neoplasm Malignant Ovarian Clear Cell Tumor Malignant Ovarian Endometrioid Tumor Malignant Ovarian Epithelial Tumor Malignant Ovarian Mucinous Tumor Malignant Peritoneal Neoplasm Malignant Solid Neoplasm Ovarian Carcinosarcoma Ovarian Clear Cell Adenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Adenocarcinoma Ovarian Serous Adenocarcinoma Ovarian Transitional Cell Carcinoma Ovarian Undifferentiated Carcinoma Platinum-Resistant Fallopian Tube Carcinoma Platinum-Resistant Ovarian Carcinoma Platinum-Resistant Primary Peritoneal Carcinoma Platinum-Sensitive Ovarian Carcinoma Primary Peritoneal Carcinosarcoma Primary Peritoneal Clear Cell Adenocarcinoma Primary Peritoneal Serous Adenocarcinoma Primary Peritoneal Transitional Cell Carcinoma Primary Peritoneal Undifferentiated Carcinoma Stage IV Cutaneous Melanoma AJCC v6 and v7 Unresectable Melanoma Uterine Corpus Carcinosarcoma||Biological: Bevacizumab Other: Laboratory Biomarker Analysis Drug: Nab-paclitaxel Other: Pharmacological Study||Phase 1|
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
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeted Complex Therapy for Advanced Melanoma, Gynecologic Cancers, and Other Malignancies: Nab-Paclitaxel (Abraxane)/Bevacizumab Complex (AB-Complex)|
|Actual Study Start Date :||March 26, 2014|
|Estimated Primary Completion Date :||February 3, 2022|
|Estimated Study Completion Date :||June 1, 2025|
Experimental: Treatment (AB-complex)
Patients receive nab-paclitaxel/bevacizumab-complex 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.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Maximum tolerated dose [ Time Frame: 28 days ]Defined as the highest dose level among those under consideration where at most 1 of 6 patients develops a dose-limiting toxicity. The maximum grade of each type of toxicity will be recorded for each patient. For each toxicity reported by dose level, the percentage of patients developing any degree of that toxicity as well as the percentage of patients developing a severe degree (grade 3 or higher) will be determined.
- Tumor response [ Time Frame: Up to 12 months ]Defined as complete response or partial response on 2 consecutive evaluations at least 8 weeks apart. Will be assessed as the number of patients whose tumor has met the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria. A 90% binomial confidence interval for the tumor response rate will be determined.
- Progression-free survival (PFS) [ Time Frame: Time from study entry to the documentation of disease progression, assessed up to 12 months ]
- Overall survival (OS) [ Time Frame: Time from study entry to death due to any cause, assessed up to 12 months ]
- Incidence of adverse events (soft tissue expansion cohort) [ Time Frame: Up to 12 months ]The maximum grade of each type of adverse event will be recorded for each patient and the percentage of patients developing any degree of that adverse effect as well as the percentage of patients developing a severe degree (grade 3 or higher) will be determined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020707
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Matthew S Block||Mayo Clinic in Rochester|