NCT01132820

Cediranib Maleate in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of Cediranib (Recentin; AZD2171, IND#72740, NSC# 732208) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well cediranib maleate works in treating patients with endometrial cancer that has failed to respond to initial chemotherapy or has come back after surgery, radiation therapy, or other forms of treatment. Cediranib maleate may stop the growth of tumor cells by blocking proteins made by tumors that can stimulate growth of tumor cells as well as blood vessels in and around tumors.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. TERTIARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Endometrial Adenocarcinoma
• Endometrial Adenosquamous Carcinoma
• Endometrial Clear Cell Adenocarcinoma
• Endometrial Serous Adenocarcinoma
• Recurrent Uterine Corpus Carcinoma

Interventions

Type	Name	Description
DRUG	Cediranib Maleate	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2010-06-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2010-05-28
• Last updated: 2019-08-08
• Results posted: 2017-08-28

Locations

87 sites across 1 country: United States