Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer
This phase II trial studies the side effects and how well nintedanib works in treating patients with recurrent or persistent endometrial cancer. Nintedanib 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.
Endometrial Adenosquamous Carcinoma
Endometrial Clear Cell Adenocarcinoma
Recurrent Uterine Corpus Carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of BIBF 1120 in the Treatment of Recurrent or Persistent Endometrial Carcinoma|
- Progression-free survival without going on a subsequent therapy against the disease [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Objective tumor response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Incidence of adverse events as assessed by the National Cancer Institute CTCAE version 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- PFS [ Time Frame: The duration of time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years ] [ Designated as safety issue: No ]Characterized graphically and using descriptive statistics such as median survival.
- OS [ Time Frame: The duration of time from study entry to time of death or the date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]Characterized graphically and using descriptive statistics such as median survival.
|Study Start Date:||October 2011|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (nintedanib)
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
I. 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 and the proportion of patients who have objective tumor response (complete or partial), treated with BIBF 1120 (nintedanib).
II. To determine the nature and degree of toxicity of BIBF 1120 in this cohort of patients.
I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with BIBF 1120.
Patients receive nintedanib orally (PO) twice daily (BID) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225887
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|Principal Investigator:||Don Dizon||NRG Oncology|