Paclitaxel, Cisplatin, and Veliparib in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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
4 other identifiers
interventional
37
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2011
Longer than P75 for phase_1
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedStudy Start
First participant enrolled
March 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2017
CompletedJuly 18, 2019
July 1, 2019
5.9 years
January 21, 2011
July 17, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Dose-limiting toxicities in the first course of treatment (Phase I)
21 days
Frequency and severity of adverse effects as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v. 4.0
Within 30 days of last protocol treatment
Objective tumor response (complete or partial response) (Phase II)
Up to 5 years
Secondary Outcomes (2)
Progression-free survival (Phase II)
From study entry to time of progression or death, whichever occurs first, assessed up to 5 years
Overall survival (Phase II)
From study entry to time of death or the date of last contact, assessed up to 5 years
Other Outcomes (1)
Proportion of patients with tumors that demonstrate loss of the FancD2 foci formation
Baseline
Study Arms (1)
Treatment (paclitaxel, cisplatin, veliparib)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given IV
Given PO
Eligibility Criteria
You may qualify if:
- Patients must have primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy; histologic documentation of the original primary tumor is required via the pathology report
- All patients in the phase II portion must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measureable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI; measurable disease is not required for participation in the phase I portion of this study
- Patients in the phase II portion must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Patients must have a Gynecologic Oncology Group (GOG) Performance Status of 0, 1, or 2
- Recovery from effects of recent surgery, radiotherapy or other therapy
- Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\])
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
- At least six weeks must have elapsed from the last administration of chemoradiotherapy, and at least three weeks must have elapsed from the last administration of radiation therapy alone; at least six weeks must have elapsed from the time of any major surgical procedure prior to randomization
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
- Platelets greater than or equal to100,000/mcl
- Hemoglobin \>= 9 gm/dL
- Creatinine less than or equal to institutional upper limit normal (ULN) or calculated creatinine clearance (Cockcroft-Gault) \>= 60 ml/min
- Calcium, magnesium, phosphate, and potassium levels within institutional normal limits
- Bilirubin less than or equal to 1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN
- +6 more criteria
You may not qualify if:
- Patients with prior treatment with ABT-888 or other poly adenosine phosphate (ADP) ribose polymerase (PARP) inhibitors
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of the other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of cervical cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of cervical cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
- Patients previously treated with chemotherapy for cervical cancer except when used concurrently with radiation therapy and/or as adjuvant therapy
- Chemotherapy administered concurrent with primary radiation (e.g., weekly cisplatin) is allowed; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is allowed (e.g., paclitaxel and carboplatin for up to 4 cycles)
- Patients may not be receiving any other investigational agents
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or other agents used in study
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ABT-888
- Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study
- Patients who are unable to swallow medication
- Patients who are breast feeding should be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- NRG Oncologycollaborator
Study Sites (25)
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Related Publications (1)
Thaker PH, Salani R, Brady WE, Lankes HA, Cohn DE, Mutch DG, Mannel RS, Bell-McGuinn KM, Di Silvestro PA, Jelovac D, Carter JS, Duan W, Resnick KE, Dizon DS, Aghajanian C, Fracasso PM. A phase I trial of paclitaxel, cisplatin, and veliparib in the treatment of persistent or recurrent carcinoma of the cervix: an NRG Oncology Study (NCT#01281852). Ann Oncol. 2017 Mar 1;28(3):505-511. doi: 10.1093/annonc/mdw635.
PMID: 27998970DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ritu Salani
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2011
First Posted
January 24, 2011
Study Start
March 14, 2011
Primary Completion
February 11, 2017
Study Completion
February 11, 2017
Last Updated
July 18, 2019
Record last verified: 2019-07