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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase IBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2011-02661
GOG-0076HH, CDR0000693745, U10CA027469, NCT01281852

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

Inclusion Criteria:

  • Patients must have primary stage IVB, recurrent, or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiotherapy
  • Histologic documentation of the original primary tumor is required via the pathology report
  • All patients in the phase I portion must have received prior chemoradiation
  • Measurable disease not required for patients in the phase I portion
  • All patients in the phase II portion must have measurable disease as defined by RECIST 1.1
  • Measurable 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 CT scan, 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 scan or MRI
  • 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 radiotherapy
  • No patients with history or evidence, upon physical examination, of CNS disease, including primary brain tumor or brain metastases, within the past 6 months of the first date of treatment on this study
  • GOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Calcium, magnesium, phosphate, and potassium normal
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Women of child-bearing potential must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation
  • Able to swallow medication
  • Free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
  • Peripheral neuropathy (sensory and motor) ≤ grade 1
  • No history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, within the past 3 years.
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in study
  • No 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
  • No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within the past 6 months of the first date of treatment on this study
  • No other concurrent investigational agents
  • Recovered from effects of recent surgery, radiotherapy, or other therapy
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • Continuation of hormone replacement therapy is permitted
  • At least 6 weeks since prior chemoradiotherapy
  • At least 3 weeks since prior radiotherapy alone
  • At least 6 weeks since prior major surgery
  • No prior cancer treatment that contraindicates this protocol therapy
  • No prior veliparib or other PARP inhibitors
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of cervical cancer within the last 3 years
  • Prior radiotherapy for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease
  • No prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of cervical cancer within the last 3 years
  • Prior adjuvant chemotherapy for localized breast cancer allowed, provided that it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease
  • No prior chemotherapy for cervical cancer except when used concurrently with radiotherapy
  • No patients who have received concurrent paclitaxel with radiation therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Ritu SalaniPrincipal Investigator

Trial Sites

U.S.A.
California
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Huyen Q Pham Ph: 323-865-0451
Georgia
  Augusta
 Medical College of Georgia Cancer Center
 Sharad Anant Ghamande Ph: 706-721-1663
  Email: cancer@georgiahealth.edu
Illinois
  Chicago
 University of Chicago Cancer Research Center
 Meaghan E Tenney Ph: 773-834-7424
  Email: julie-traylor@ouhsc.edu
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 David P Bender Ph: 800-237-1225
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Deborah K. Armstrong Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 James Tate Thigpen Ph: 601-815-6700
  Pascagoula
 Regional Cancer Center at Singing River Hospital
 James E. Clarkson Ph: 228-809-5292
Missouri
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Gardner Mutch Ph: 800-600-3606
  Email: info@ccadmin.wustl.edu
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Mario M Leitao Ph: 212-639-7202
Ohio
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 David M O'Malley Ph: 866-627-7616
  Email: osu@emergingmed.com
 Ritu Salani Ph: 614-366-9427
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Tulsa
 Cancer Care Associates-Yale
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Philadelphia
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Russell J. Schilder Ph: 215-728-4790
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Cara A Mathews Ph: 401-274-1122
  Email: julie-traylor@ouhsc.edu
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Jennifer L Young Pierce Ph: 843-792-9321
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 David Scott Miller Ph: 214-648-7097
  Houston
 Lyndon B. Johnson General Hospital
 Lois M. Ramondetta Ph: 713-792-3245
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Susan C Modesitt Ph: 434-243-6143
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Andrew Poklepovic Ph: 804-628-1939

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01281852
ClinicalTrials.gov processed this data on October 20, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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