Clinical Trial: Cediranib Maleate in Treating Patients With Recurrent or Persistent Endometrial Cancer

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

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

Brief 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 Summary:

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), a
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Incidence of adverse effects as assessed by the National Cancer Institute CTCAE v. 4.0 [ Time Frame: Up to 5 years ]
  • Objective tumor response according to RECIST v. 1.1. [ Time Frame: Within 6 months of study entry ]
  • Progression-free survival (PFS) according to RECIST v. 1.1 [ Time Frame: For at least 6 months ]


Original Primary Outcome:

  • Frequency of progression-free survival for at least 6 months
  • Objective tumor response within 6 months
  • Frequency and severity of adverse effects as assessed by NCI CTCAE


Current Secondary Outcome:

  • Overall survival [ Time Frame: Up to 5 years ]
  • 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 ]
  • Response without regard to the time of documented response [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

  • Duration of progression-free survival and overall survival
  • Frequency of response without regard to the time of documented response


Information By: National Cancer Institute (NCI)

Dates:
Date Received: May 27, 2010
Date Started: June 2010
Date Completion:
Last Updated: April 20, 2016
Last Verified: April 2016