Spots Global Cancer Trial Database for Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
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Trial Identification
Brief Title: Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
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
Study ID: NCT01720173
Study Description
Brief Summary: This phase II trial studies the side effects and how well dalantercept works in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer that has returned. Dalantercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Dalantercept may also stop the growth of tumor cells by blocking blood flow to the tumor.
Detailed Description: PRIMARY OBJECTIVES: 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). SECONDARY OBJECTIVES: I. To determine the duration of progression-free survival (PFS) and overall survival (OS). TERTIARY OBJECTIVES: 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. OUTLINE: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Poudre Valley Hospital, Fort Collins, Colorado, United States
Hartford Hospital, Hartford, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Maine Medical Center-Bramhall Campus, Portland, Maine, United States
Christiana Care - Union Hospital, Elkton, Maryland, United States
UMass Memorial Medical Center - Memorial Division, Worcester, Massachusetts, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Jefferson Abington Hospital, Abington, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford NCI Community Oncology Research Program of the North Central Plains, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
The Don and Sybil Harrington Cancer Center, Amarillo, Texas, United States
Pacific Gynecology Specialists, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Washington Medical Center - Northwest, Seattle, Washington, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Contact Details
Name: Robert A Burger
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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