Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Recruitment status was: Active, not recruiting
|Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Biological: Dalantercept Other: Laboratory Biomarker Analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Dalantercept (NSC #757172), a Novel Soluble Recombinant Activin Receptor-Like Kinase 1 (ALK-1) Inhibitor Receptor-Fusion Protein, in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma|
- Proportion of patients who survive progression-free (without non-protocol therapy) for at least 6 months after study entry or have objective tumor response (complete or partial) [ Time Frame: 6 months ]
- Frequency and severity of adverse effects as assessed by CTCAE [ Time Frame: Up to 5 years ]
- Duration of progression-free survival (PFS) [ Time Frame: Time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]Will be characterized with Kaplan-Meier plots and estimates of the median time until progression.
- Duration of overall survival (OS) [ Time Frame: From study entry to time of death or the date of last contact, assessed up to 5 years ]Will be characterized with Kaplan-Meier plots and estimates of the median time until death.
- IHC expression levels of VEGF, FGF, TGFB, ALK1, CD105 and other markers [ Time Frame: Baseline ]Associated with measures of clinical response to treatment, including PFS and OS.
- Gene expression levels of ALK1 and other markers [ Time Frame: Baseline ]Associated with measures of clinical response to treatment, including PFS and OS.
- Pre-treatment plasma concentration levels of VEGF, BMP9, BMP10, and ALK1 [ Time Frame: Baseline ]Associated with measures of clinical response to treatment, including PFS and OS.
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (dalantercept)
Patients receive dalantercept SC on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Other Names:Other: Laboratory Biomarker Analysis
I. To estimate the proportion of patients who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial) in patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, treated with dalantercept.
II. To determine the frequency and severity of adverse events associated with treatment with dalantercept as assessed by the Active Version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
I. To determine the duration of progression-free survival (PFS) and overall survival (OS).
I. To measure the expression of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-B), activin receptor-like kinase 1 (ALK1), cluster of differentiation 105 (CD105), and other markers via immunohistochemistry (IHC) and determine if there is correlation between expression and clinical response to treatment.
II. To determine the correlation between ALK1 gene expression, other markers, and clinical response to treatment.
III. To determine the correlation between concentration of VEGF, bone morphogenetic protein (BMP)9, BMP10, and ALK1 in pre-cycle 1 plasma using an enzyme-linked immunosorbent assay (ELISA), and clinical response to treatment.
Patients receive dalantercept subcutaneously (SC) on day 1. Courses repeat every 3 weeks 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: NCT01720173
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|Principal Investigator:||Robert Burger||NRG Oncology|