Paclitaxel, Cisplatin, and Veliparib in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

Completed · Phase 1

Conditions studied: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Recurrent Cervical Carcinoma, Stage IVB Cervical Cancer AJCC v6 and v7

In brief

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.

Key facts

Study ID

NCT01281852

Run by

National Cancer Institute (NCI)

People needed

37

Starts

2011-03-14

Expected to finish

2017-02-11

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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
• Alkaline phosphatase less than or equal to 2.5 x ULN
• Neuropathy (sensory and motor) less than or equal to grade 1
• Patients must have signed an approved informed consent and authorization permitting release of personal health information
• Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• PHASE I: All patients must have received prior chemoradiation
• PHASE I: Patients do not need to have measurable disease

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

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Singing River Hospital — Pascagoula, Mississippi, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Hillcrest Hospital Cancer Center — Mayfield Heights, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Oklahoma Cancer Specialists and Research Institute-Tulsa — Tulsa, Oklahoma, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
• Lyndon Baines Johnson General Hospital — Houston, Texas, United States
• M D Anderson Cancer Center — Houston, Texas, United States
• University of Virginia Cancer Center — Charlottesville, Virginia, United States
• Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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