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

Status
Active
Cancer Type
Cervical Cancer
Trial Phase
Phase I
Phase II
Eligibility
18 and over, Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01281852
Protocol IDs
NCI-2011-02661 (primary)
GOG-0076HH
U10CA027469
CDR0000693745
Study Sponsor
National Cancer Institute

Summary

This phase I/II clinical trial is studying the side effects and the best dose of veliparib when given with paclitaxel and cisplatin and to see how well they work in treating patients with advanced, persistent, or recurrent cervical cancer. 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 or by stopping them from dividing. 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

Objectives

PRIMARY OBJECTIVES:

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 cervical cancer.

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.

SECONDARY OBJECTIVES:

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.

Treatment Sites in Georgia


Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/