Clinical Trial: Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery or Gynecological Cancers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Targeted Complex Therapy for Advanced Melanoma and Gynecologic Cancers: Nab-Paclitaxel (Abraxane)/Bevacizumab Complex (AB-Complex)

Brief Summary: This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma that cannot be removed by surgery or with cancer of the cervix, endometrium, ovary, fallopian tube or peritoneal cavity. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Giving paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab may kill more tumor cells.

Detailed Summary:

PRIMARY OBJECTIVES:

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.

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.

TERTIARY OBJECTIVES:

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.


Sponsor: Mayo Clinic

Current Primary Outcome: 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.


Original Primary Outcome: 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.


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Tumor response defined as complete response (CR) or partial response (PR) on 2 consecutive evaluations at least 8 weeks apart assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 12 months ]

Information By: Mayo Clinic

Dates:
Date Received: December 19, 2013
Date Started: March 2014
Date Completion: January 2018
Last Updated: April 21, 2017
Last Verified: February 2017