Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer
NCT ID: NCT01266447
Last Updated: 2019-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2011-02-28
2016-01-31
Brief Summary
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Detailed Description
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I. To estimate the antitumor activity (objective response rate by RECIST 1.1) of ABT-888 (veliparib) 10 mg administered orally twice a day on days 1 to 5 with topotecan (topotecan hydrochloride) 0.6 mg/m\^2 administered IV once daily on days 1 to 5 of each cycle in patients with persistent or recurrent carcinoma of the cervix.
II. To determine the nature and degree of toxicity of ABT-888 and topotecan in patients with persistent or recurrent carcinoma of the cervix.
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival and overall survival.
TERTIARY OBJECTIVES:
I. To determine whether evidence of an interaction exists between study treatments and tumor expression of poly(ADP-ribos)ylation of E2 protein, E6/E7 proteins, and p53R2 in relation to progression-free and overall survival or metastasis. (Translational) II. To explore the association between methylation of FanCF and BRCA in pre-treatment tumor samples and pre- and post-treatment biopsy samples and response, progression-free and overall survival of patients, and/or metastasis. (Translational)
OUTLINE:
Patients receive veliparib orally (PO) twice daily and topotecan hydrochloride intravenously (IV) over 30 minutes once daily on days 1-5. Patients also receive, according to institutional standard, filgrastim subcutaneously (SC) beginning on day 6, 7, or 8 and continuing until hematopoietic recovery or pegfilgrastim SC on day 6, 7, or 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples may be collected periodically for translational studies.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (veliparib, topotecan hydrochloride, filgrastim)
Patients receive veliparib PO twice daily and topotecan hydrochloride IV over 30 minutes once daily on days 1-5. Patients also receive, according to institutional standard, filgrastim SC beginning on day 6, 7, or 8 and continuing until hematopoietic recovery or pegfilgrastim SC on day 6, 7, or 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Filgrastim
Given SC
Laboratory Biomarker Analysis
Correlative studies
Pegfilgrastim
Given SC
Topotecan Hydrochloride
Given IV
Veliparib
Given PO
Interventions
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Filgrastim
Given SC
Laboratory Biomarker Analysis
Correlative studies
Pegfilgrastim
Given SC
Topotecan Hydrochloride
Given IV
Veliparib
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients 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 diameter 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
* Patient 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 not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population
* Patients must have a GOG performance status of 0, 1, or 2
* Recovery from effects of recent surgery, radiotherapy, or chemotherapy
* Patients should be free of active infection requiring antibiotics
* 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
* Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted (non-cytotoxic) therapy and immunologic agents must be discontinued at least three weeks prior to registration; all side effects must have resolved to =\< grade 1 or stabilized, prior to enrolling on this study
* Any prior radiation therapy must be completed at least 4 weeks prior to registration
* Patients MUST have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent squamous or non-squamous cell carcinoma of the cervix; chemotherapy administered concurrent with primary radiation is not counted as a systemic chemotherapy regimen (e.g.; weekly cisplatin); adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen (e.g.; paclitaxel and carboplatin for up to 4 cycles)
* Patients who are registered during the safety lead-in portion of this protocol are required to have prior pelvic radiation
* Patients must have NOT received more than one previous cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
* Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their one prior systemic chemotherapeutic regimen; patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy for management of recurrent or persistent disease
* Patients MUST not be eligible for further curative intent surgical or pelvic radiation treatment for management of recurrent or persistent disease as determined by treating physicians
* Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
* Platelets greater than or equal to 100,000/mcl
* Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
* 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 must meet pre-entry requirements
* Women of child-bearing potential and men 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
* Patients must have the ability to swallow pills whole
Exclusion Criteria
* Patient 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 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 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 with seizures or history of seizures are ineligible
* Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any CNS metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study, are ineligible; patients with CNS metastases must be stable for \> 3 months after treatment and off steroid treatment prior to study enrollment
18 Years
FEMALE
No
Sponsors
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NRG Oncology
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Charles Kunos
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Florida Hospital Orlando
Orlando, Florida, United States
Memorial University Medical Center
Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 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
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium CCOP
Ann Arbor, Michigan, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
State University of New York Downstate Medical Center
Brooklyn, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
North Shore-LIJ Health System/Center for Advanced Medicine
New Hyde Park, New York, United States
Case Western Reserve University
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Lake University Ireland Cancer Center
Mentor, 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
Abington Memorial Hospital
Abington, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
University Medical Center Brackenridge
Austin, Texas, United States
Parkland Memorial Hospital
Dallas, Texas, United States
Zale Lipshy University Hospital
Dallas, Texas, United States
Clements University Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
PeaceHealth Medical Group PC
Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States
Harrison Medical Center
Bremerton, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Skagit Valley Hospital Regional Cancer Care Center
Mount Vernon, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Group Health Cooperative-Seattle
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
Northwest Hospital
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Olympic Medical Cancer Care Center
Sequim, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
D N Greenwald Center
Mukwonago, Wisconsin, United States
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Countries
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Other Identifiers
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NCI-2011-02659
Identifier Type: REGISTRY
Identifier Source: secondary_id
GOG-0127W
Identifier Type: -
Identifier Source: secondary_id
CDR0000691281
Identifier Type: -
Identifier Source: secondary_id
GOG-0127W
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0127W
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02659
Identifier Type: -
Identifier Source: org_study_id
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