Cediranib Maleate in Treating Patients With Recurrent or Persistent Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT01132820|
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Serous Adenocarcinoma Recurrent Uterine Corpus Carcinoma||Drug: Cediranib Maleate Other: Laboratory Biomarker Analysis||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Cediranib (Recentin; AZD2171, IND#72740, NSC# 732208) in the Treatment of Recurrent or Persistent Endometrial Carcinoma|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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: Laboratory Biomarker Analysis
- Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0 [ Time Frame: Up to 5 years ]Adverse Events (Grade 3 or higher)
- Tumor Response [ Time Frame: For diesease evaluated by physical examination, response was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle from enrollment until stopping study therapy. The average time on study is 3 mnths ]Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR.
- Progression-free Survival (PFS) = > 6 Months [ Time Frame: For disease evaluated by physical examination, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. Evaluated from time of enrollment until progression or death, up to 5 years ]Number of participants who survived for at least 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years. ]The observed length of life from entry into the study to death or the date of last contact.
- Progression Free Survival [ Time Frame: Disease that can be assessed by physical exam should be evaluated every cycle. disease assessed by imaging should be evaluated every other cycle. Time frame to determine the date of progression is from the date of enrollment up to 5 years after enrollment ]Time until disease progression, death, or date of last contact.
- Response Without Regard to the Time of Documented Response [ Time Frame: Tumor responses with time restriction starts at enrollment and goes to 6 months after enrollment or until pt. off study therapy,whichever occurs first. Without time restriction starts at enrollment,lasts until off study therapy, median duration = 2.63 mth ]Complete and partial tumor response by RECIST 1.1
- Expression of Phosphorylated ERK1 and 2, c-Jun, Stat3, PKC, and p70S6 Kinase [ Time Frame: Baseline ]
- Levels of Receptor Targets Such as VEGFR (1, 2, 3) and PDGFR [ Time Frame: Baseline ]
- 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 ]
- VEGFA Expression on Pre-treatment Tumor Specimens [ Time Frame: Baseline ]High vs low expression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132820
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|Principal Investigator:||David Bender||NRG Oncology|