Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer
RATIONALE: Dalantercept may stop the growth of endometrial cancer by blocking blood flow to the tumor.
PURPOSE: This phase II trial studies how well dalantercept works in treating patients with recurrent or persistent endometrial cancer.
Genetic: gene expression analysis
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: enzyme-linked immunosorbent assay
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Dalantercept, a Novel Soluble Recombinant Activin Receptor-Like Kinase (ALK-1) Inhibitor Receptor-Fusion Protein, in the Treatment of Recurrent or Persistent Endometrial Carcinoma|
- PFS until subsequent therapy for at least 6 months as measured by RECIST [ Designated as safety issue: No ]
- Objective tumor response (complete or partial response) as measured by RECIST, assessed up to 5 years [ Designated as safety issue: No ]
- PFS characterized graphically and using descriptive statistics such as median survival, assessed up to 5 years [ Designated as safety issue: No ]
- OS characterized graphically and using descriptive statistics such as median survival, assessed up to 5 years [ Designated as safety issue: No ]
- Adverse events, as assessed by CTCAE, for up to 21 days [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
- To estimate the proportion of patients with persistent or recurrent endometrial cancer who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial) when treated with dalantercept.
- To determine the nature and degree of toxicity of dalantercept in this cohort of patients.
- To estimate progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with dalantercept.
- To measure the expression of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), activin receptor-like kinase 1 (ALK1), endoglin (CD105), and other markers via immunohistochemistry (IHC) and determine if there is correlation between expression and clinical response to treatment.
- To determine the correlation between ALK1 gene expression, other markers, and clinical response to treatment.
- To determine the correlation between concentration of VEGF, bone morphogenetic protein 9 (BMP9), bone morphogenetic protein 10 (BMP10), and ALK1 in pre-cycle 1 plasma using an enzyme-linked immunosorbent assay (ELISA), and clinical response to treatment.
- To correlate somatic mutations in candidate genes with response to therapy.
OUTLINE: This is a multicenter study.
Patients receive dalantercept subcutaneously (SC) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for VEGF, FGF, PDGF, TGF-β, ALK1, CD105, ALK1, BMP9, and BMP10 protein analysis and gene expression by IHC, ELISA, and reverse transcriptase polymerase chain reaction (RT-PCR).
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222|
|United States, Florida|
|Florida Hospital Cancer Institute at Florida Hospital Orlando||Recruiting|
|Orlando, Florida, United States, 32803-1273|
|Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623|
|United States, Illinois|
|University of Chicago Cancer Research Center||Recruiting|
|Chicago, Illinois, United States, 60637-1470|
|Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424|
|United States, Indiana|
|St. Vincent Oncology Center||Recruiting|
|Indianapolis, Indiana, United States, 46260|
|Contact: Gregory P. Sutton, MD 317-415-6740|
|United States, Maine|
|Maine Medical Center - Bramhall Campus||Recruiting|
|Portland, Maine, United States, 04102|
|Contact: Clinical Trials Office - Maine Medical Center - Bramhall Camp 207-885-7565|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Vicky Makker 212-639-8895|
|United States, North Carolina|
|Presbyterian Cancer Center at Presbyterian Hospital||Recruiting|
|Charlotte, North Carolina, United States, 28233-3549|
|Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369|
|Wake Forest University Comprehensive Cancer Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771|
|United States, Oklahoma|
|Oklahoma University Cancer Institute||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Robert S. Mannel, MD 405-271-8787|
|United States, Pennsylvania|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Recruiting|
|Abington, Pennsylvania, United States, 19001|
|Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M 215-481-2402|
|United States, Texas|
|Harrington Cancer Center||Recruiting|
|Amarillo, Texas, United States, 79106|
|Contact: Clinical Trials Officec - Harrington Cancer Center 806-359-4673 firstname.lastname@example.org|
|Principal Investigator:||Vicky Makker, MD||Memorial Sloan-Kettering Cancer Center|