Paclitaxel, Cisplatin, and Veliparib in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
|Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Recurrent Cervical Carcinoma Stage IVB Cervical Cancer||Drug: Cisplatin Other: Laboratory Biomarker Analysis Drug: Paclitaxel Drug: Veliparib||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Limited Access Phase I/II 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|
- Dose-limiting toxicities in the first course of treatment (Phase I) [ Time Frame: 21 days ]
- Frequency and severity of adverse effects as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v. 4.0 [ Time Frame: Within 30 days of last protocol treatment ]
- Objective tumor response (complete or partial response) (Phase II) [ Time Frame: Up to 5 years ]
- Overall survival (Phase II) [ Time Frame: From study entry to time of death or the date of last contact, assessed up to 5 years ]
- Progression-free survival (Phase II) [ Time Frame: From study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]
- Proportion of patients with tumors that demonstrate loss of the FancD2 foci formation [ Time Frame: Baseline ]The loss of FancD2 foci formation is associated with progression-free survival, overall survival, and response.
|Study Start Date:||March 2011|
|Study Completion Date:||February 2017|
|Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (paclitaxel, cisplatin, veliparib)
Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IV over 1 hour on day 2, and veliparib PO on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Paclitaxel
Other Names:Drug: Veliparib
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.
I. To examine the effects of this regimen on progression-free survival and overall survival.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281852
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|Principal Investigator:||Ritu Salani||NRG Oncology|