A Limited Access Phase I/II Trial of Paclitaxel, Cisplatin and CTEP Supplied Agent ABT-888 (Veliparib) (IND#77840, NSC#737664) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix
I. To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities of veliparib
when combined with cisplatin and paclitaxel in women with advanced, persistent, or recurrent
II. To examine the safety of veliparib when combined with cisplatin and paclitaxel.
III. To estimate the efficacy of cisplatin, paclitaxel, and veliparib (with respect to
objective tumor response) in patients with advanced, persistent, or recurrent carcinoma of
the cervix once the recommended phase II dose is established.
I. To examine the effects of this regimen on progression-free survival and overall survival.
II. To determine the proportion of patients with advanced, persistent, or recurrent cancer
of the cervix whose tumors demonstrate loss of the FancD2 foci formation. (Exploratory) III.
To determine the association between loss of FancD2 foci formation and progression-free
survival, overall survival, and response in this patient population. (Exploratory)
OUTLINE: This is a multicenter, phase I, dose-escalation study of veliparib followed by a
phase II study. Patients in phase II are stratified according to prior cisplatin as a
radiation sensitizer (yes vs no).
Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IV over 1 hour on day 2, and
veliparib orally on days 1-7. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity. Tumor tissue samples may be collected for FancD2 foci
formation analysis by IHC.
After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicities in the first course of treatment (phase I)
Gynecologic Oncology Group
United States: Food and Drug Administration
|Johns Hopkins University||Baltimore, Maryland 21205|
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|Cleveland Clinic Foundation||Cleveland, Ohio 44195|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|University of Mississippi Medical Center||Jackson, Mississippi 39216-4505|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|MetroHealth Medical Center||Cleveland, Ohio 44109|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Singing River Hospital||Pascagoula, Mississippi 39581|
|University of Virginia||Charlottesville, Virginia 22908|
|Case Western Reserve University||Cleveland, Ohio 44106|
|Riverside Methodist Hospital||Columbus, Ohio 43214|
|University of Texas Southwestern Medical Center||Dallas, Texas|
|Virginia Commonwealth University||Richmond, Virginia|
|Hillcrest Hospital Cancer Center||Mayfield Heights, Ohio 44124|
|Cancer Care Associates-Yale||Tulsa, Oklahoma 74136-1929|
|Women and Infants Hospital||Providence, Rhode Island 02905|
|Georgia Health Sciences University||Augusta, Georgia 30912|
|Gynecologic Oncology Group||Philadelphia, Pennsylvania 19103|