Paclitaxel, Cisplatin, and Veliparib in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
This phase I/II 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.
Cervical Adenosquamous Cell Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Cancer
Stage IVB Cervical Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Objective tumor response (complete or partial response) (Phase II) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Progression-free survival (Phase II) [ Time Frame: From study entry to time of progression or death, whichever occurs first, assessed up to 5 years ] [ Designated as safety issue: No ]
- Overall survival (Phase II) [ Time Frame: From study entry to time of death or the date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
- Proportion of patients with tumors that demonstrate loss of the FancD2 foci formation [ Time Frame: Baseline ] [ Designated as safety issue: No ]The loss of FancD2 foci formation is associated with progression-free survival, overall survival, and response.
|Study Start Date:||April 2011|
|Estimated Primary Completion Date:||March 2020 (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 Name: ABT-888Drug: cisplatin
Other Names:Drug: paclitaxel
Other Names:Other: laboratory biomarker analysis
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|