BIBF 1120 in Treating Patients With Recurrent or Persistent Endometrial Cancer
RATIONALE: BIBF 1120 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.
PURPOSE: This phase II trial is studying the side effects and how well BIBF 1120 works in treating patients with recurrent or persistent endometrial cancer.
Drug: multitargeted tyrosine kinase inhibitor BIBF 1120
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of BIBF 1120 (IND #) in the Treatment of Recurrent or Persistent Endometrial Carcinoma|
- Progression-free survival for at least 6 months [ Designated as safety issue: No ]
- Objective tumor response [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE v. 4.0 [ Designated as safety issue: Yes ]
- Progression-free survival and overall survival [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
- To estimate the proportion of patients with persistent or recurrent endometrial cancer, who survive progression-free without going on a subsequent therapy against the disease for at least 6 months
- To assess objective tumor response (complete or partial) in patients with recurrent or persistent endometrial carcinoma treated with BIBF 1120.
- To determine the nature and degree of toxicity of BIBI 1120 in these patients.
- To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with BIBF 1120.
OUTLINE: This is a multicenter study.
Patients receive oral BIBF 1120 twice daily 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.