Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer
NCT ID: NCT00087126
Last Updated: 2019-01-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2005-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This phase II trial is studying how well topotecan works in treating women with persistent or recurrent cervical cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
NCT00016926
Carboplatin and Topotecan in Treating Patients With Relapsed or Metastatic Cervical Cancer
NCT00807079
Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix
NCT00006224
Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix
NCT00003065
Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer
NCT00039442
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the antitumor activity of topotecan in patients with persistent or recurrent carcinoma of the cervix that failed higher priority treatment protocols.
* Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patient are followed for every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-2 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Topotecan
Topotecan weekly
topotecan hydrochloride
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
topotecan hydrochloride
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Age
* 18 and over
Performance status
* GOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Other
* Sensory or motor neuropathy ≤ grade 1
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics
* No other malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following:
* Monoclonal antibodies
* Cytokines
* Small-molecule inhibitors of signal transduction
* At least 3 weeks since prior biologic or immunologic agents for cervical cancer
* No concurrent prophylactic growth factors, including filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim
* No concurrent prophylactic thrombopoietic agents
Chemotherapy
* See Disease Characteristics
* Recovered from prior chemotherapy
* No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
* No prior topotecan
Endocrine therapy
* At least 1 week since prior hormonal therapy for cervical cancer
* Concurrent hormone replacement therapy allowed
Radiotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
Surgery
* Recovered from prior surgery
Other
* At least 3 weeks since other prior therapy for cervical cancer
* No prior cancer therapy that would preclude study participation
18 Years
120 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James V. Fiorica, MD
Role: STUDY_CHAIR
Sarasota Memorial Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Olive View - UCLA Medical Center Foundation
Sylmar, California, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fiorica JV, Blessing JA, Puneky LV, Secord AA, Hoffman JS, Yamada SD, Buekers TE, Bell J, Schilder JM; Gynecologic Oncology Group. A Phase II evaluation of weekly topotecan as a single agent second line therapy in persistent or recurrent carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol. 2009 Nov;115(2):285-9. doi: 10.1016/j.ygyno.2009.07.024. Epub 2009 Sep 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GOG-0127U
Identifier Type: -
Identifier Source: secondary_id
CDR0000372930
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0127U
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.