Clinical Trial: Brivanib Alaninate in Treating Patients With Persistent or Recurrent Cervical Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Evaluation of Brivanib (BMS582664) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix (BMS Study CA182-048)

Brief Summary: This phase II trial studies how well brivanib alaninate works in treating patients with cervical cancer that has come back. Brivanib alaninate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To estimate the proportion of patients with persistent or recurrent cervical cancer, who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with brivanib (brivanib alaninate).

II. To determine the nature and degree of toxicity of brivanib in this cohort of patients.

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent cervical cancer treated with brivanib.

TERTIARY OBJECTIVES:

I. To obtain the serum expression levels of surrogate markers of brivanib effects including angiogenic factors (vascular endothelial growth factor [VEGF] and basic fibroblast growth factor [bFGF]) and markers of endothelial damage (E-selectin, vascular cell adhesion molecule 1 [VCAM-1], and (intercellular adhesion molecule 1 [ICAM-1]). (exploratory) II. To determine whether these marker expression levels alone or in combination are associated with response, PFS, or overall survival. (exploratory)

OUTLINE:

Patients receive brivanib alaninate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.


Sponsor: Gynecologic Oncology Group

Current Primary Outcome:

  • Objective Tumor Response [ Time Frame: Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. ]
    Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response assessed by RECIST 1.1
  • PFS for at Least 6 Months Without Non-protocol Therapy From Study Entry. [ Time Frame: Every other cycle for first 6 months; then every 3 months therafter until disease progression confirmed; and at any other time if cliniclly indicated based on symptoms or physical signs suggestive of progressive disease ]
    Proportion of participants who survive progression-free for at least 6 months without non-protocol therapy from study entry. Progression is assessed by RECIST 1.1.
  • Adverse Events (Grade 3 or Higher) During Treatment Period [ Time Frame: During treatment period and up to 30 days after stopping the study treatment. ]
    Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v.4.0


Original Primary Outcome:

  • Progression-free for at least 6 months
  • Objective tumor response (complete or partial)
  • Adverse events as assessed by NCI CTCAE v4.0


Current Secondary Outcome:

  • Progression-free Survival [ Time Frame: From study entry to time of progression or death, whichever occurs first, up to 5 years of follow-up ]
    Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1
  • Overall Survival [ Time Frame: From study entry to time of death or the date of last contact, up to 5 years of follow-up. ]
    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact..


Original Secondary Outcome:

  • Progression-free Survival
  • Overall Survival


Information By: Gynecologic Oncology Group

Dates:
Date Received: December 24, 2010
Date Started: April 2011
Date Completion:
Last Updated: January 26, 2017
Last Verified: January 2017