Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery or Gynecological Cancers
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|ClinicalTrials.gov Identifier: NCT02020707|
Recruitment Status : Recruiting
First Posted : December 25, 2013
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cervical Adenosarcoma Cervical Adenosquamous Carcinoma Cervical Carcinosarcoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Endometrial Clear Cell Adenocarcinoma Endometrial Endometrioid Adenocarcinoma Endometrial Mixed Adenocarcinoma Endometrial Mucinous Adenocarcinoma Endometrial Squamous Cell Carcinoma Endometrial Transitional Cell Carcinoma Endometrial Undifferentiated Carcinoma Fallopian Tube Adenocarcinoma Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Mucinous Adenocarcinoma Fallopian Tube Serous Adenocarcinoma Fallopian Tube Transitional Cell Carcinoma Malignant Ovarian Epithelial Tumor Malignant Peritoneal Neoplasm Ovarian Carcinosarcoma Ovarian Clear Cell Adenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Adenocarcinoma Ovarian Serous Adenocarcinoma Ovarian Transitional Cell Carcinoma Primary Peritoneal Serous Adenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Melanoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Stage IV Skin Melanoma Undifferentiated Fallopian Tube Carcinoma Undifferentiated Ovarian Carcinoma Uterine Corpus Carcinosarcoma||Biological: Bevacizumab Other: Laboratory Biomarker Analysis Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation Other: Pharmacological Study||Phase 1|
I. To determine the maximally tolerated dose (MTD-malignant melanoma [MM]) of Abraxane (paclitaxel albumin-stabilized nanoparticle formulation)/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.
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.
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 paclitaxel albumin-stabilized nanoparticle formulation/bevacizumab-complex intravenously (IV) over 30-60 minutes on days 1, 8, and 15. Courses 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 :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeted Complex Therapy for Advanced Melanoma and Gynecologic Cancers: Nab-Paclitaxel (Abraxane)/Bevacizumab Complex (AB-Complex)|
|Actual Study Start Date :||February 3, 2014|
|Estimated Primary Completion Date :||February 3, 2020|
|Estimated Study Completion Date :||June 1, 2025|
Experimental: Treatment (AB-complex)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation/bevacizumab-complex IV over 30-60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Other: Pharmacological Study
- MTD of AB-complex, defined as the highest dose level among those under consideration where at most 1 of 6 patients develops a dose-limiting toxicity [ Time Frame: 28 days ]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.
- Overall survival (OS) [ Time Frame: Time from study entry to death due to any cause, assessed up to 12 months ]
- Progression-free survival (PFS) [ Time Frame: Time from study entry to the documentation of disease progression, assessed up to 12 months ]
- Tumor response, defined as complete response or partial response on 2 consecutive evaluations at least 8 weeks apart assessed by Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 12 months ]
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, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015|
|Principal Investigator: Svetomir N. Markovic|
|Principal Investigator:||Svetomir Markovic||Mayo Clinic|