Cediranib Maleate in Treating Patients With Recurrent or Persistent Endometrial Cancer
Endometrial Adenosquamous Carcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Recurrent Uterine Corpus Carcinoma
Drug: Cediranib Maleate
Other: Laboratory Biomarker Analysis
|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 Cediranib (Recentin; AZD2171, NSC# 732208) in the Treatment of Recurrent or Persistent Endometrial Carcinoma|
- Incidence of adverse effects as assessed by the National Cancer Institute CTCAE v. 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Objective tumor response according to RECIST v. 1.1. [ Time Frame: Within 6 months of study entry ] [ Designated as safety issue: No ]
- Progression-free survival (PFS) according to RECIST v. 1.1 [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- PFS according to RECIST v. 1.1 [ Time Frame: From study entry to time of progression or death, whichever occurs first, assessed up to 5 years ] [ Designated as safety issue: No ]
- Response without regard to the time of documented response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Expression of phosphorylated ERK1 and 2, c-Jun, Stat3, PKC, and p70S6 kinase [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Levels of receptor targets such as VEGFR (1, 2, 3) and PDGFR [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Plasma levels of endogenous circulating VEGFA, levels of its endogenous inhibitor, sFlt-1 (the truncated, circulating portion of VEGFR-1), circulating TF, and circulating Par-4 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- VEGFA expression on pre-treatment tumor specimens [ Time Frame: Baseline ] [ Designated as safety issue: No ]High vs low expression.
|Study Start Date:||June 2010|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (cediranib maleate)
Patients receive cediranib maleate PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Cediranib Maleate
Other Names:Other: Laboratory Biomarker Analysis
I. To assess the activity of cediranib (cediranib maleate) in patients with either persistent or recurrent endometrial carcinoma.
II. To determine the frequency and degree of toxicity of cediranib as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.0 in this cohort of patients.
I. To determine the duration of progression-free survival and overall survival. II. To estimate the probability of response without restriction on the duration of response documentation since study enrollment.
I. To determine if the response to cediranib correlates with high-expression of its receptor targets (e.g., vascular endothelial growth factor receptor [VEGFR] [1, 2, 3] and platelet derived growth factor receptor [PDGFR]).
II. To determine if the response to cediranib correlates with high endogenous circulating plasma levels of VEGFA, low-levels of its endogenous inhibitor, soluble fms-related tyrosine kinase 3 (sFlt-1) (the truncated, circulating portion of VEGFR-1), or circulating tissue factor (TF) or circulating prostate apoptosis response-4 (Par-4), both potential markers of tumor progression.
III. To determine if a high-expression of VEGFA on pre-treatment tumor specimens correlates with response to cediranib.
IV. To determine if expression of phosphorylated mitogen activated protein kinase (ERK) 1 and 2, c-Jun, signal transducer and activator of transcription 3 (Stat3), protein kinase C (PKC), and phosphorylated ribosomal protein S6 (p70S6) kinase correlates with resistance or sensitivity to cediranib.
Patients receive cediranib maleate orally (PO) daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, 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: NCT01132820
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|Principal Investigator:||David Bender||NRG Oncology|