Spots Global Cancer Trial Database for Paclitaxel, Cisplatin, and Veliparib in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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Trial Identification
Brief Title: Paclitaxel, Cisplatin, and Veliparib in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Official Title: A Limited Access Phase I Trial of Paclitaxel, Cisplatin and CTEP Supplied Agent ABT-888 (Veliparib) (NSC#737664) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix
Study ID: NCT01281852
Study Description
Brief Summary: This phase I clinical trial studies the side effects and best dose of veliparib when given together with paclitaxel and cisplatin and to see how well they work in treating patients with cervical cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment or that has come back. Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) and giving chemotherapy together with veliparib may kill more tumor cells.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities of ABT-888 (veliparib) when combined with cisplatin and paclitaxel in women with advanced, persistent, or recurrent cervical cancer. II. To examine the safety of administering ABT-888 when combined with cisplatin and paclitaxel. III. Once the recommended phase II dose is established, to estimate the efficacy of cisplatin, paclitaxel, and ABT-888 with respect to objective tumor response in patients with advanced, persistent, or recurrent carcinoma of the cervix. SECONDARY OBJECTIVES: I. To examine the effects of this regimen on progression-free survival and overall survival. TERTIARY OBJECTIVES: I. To determine the proportion of patients with advanced, persistent, or recurrent cancer of the cervix whose tumors demonstrate loss of the Fanconi anemia group D2 (FancD2) foci formation. III. To determine the association between loss of FancD2 foci formation and progression-free survival, overall survival, and response in this patient population. OUTLINE: This is a phase I, dose-escalation study of veliparib followed by a phase II study. Patients receive paclitaxel intravenously (IV) over 3 hours on day 1, cisplatin IV over 1 hour on day 2, and veliparib orally (PO) on days 1-7. Courses repeat every 21 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Augusta University Medical Center, Augusta, Georgia, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Singing River Hospital, Pascagoula, Mississippi, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Case Western Reserve University, Cleveland, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Lyndon Baines Johnson General Hospital, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Contact Details
Name: Ritu Salani
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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