Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer
NCT ID: NCT00287911
Last Updated: 2017-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2005-02-28
2009-12-31
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cisplatin and radiation therapy in treating patients with advanced cervical cancer.
Detailed Description
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* Determine the maximum tolerated dose of topotecan when administered with cisplatin in patients with advanced cervical cancer.
* Identify any unique toxicities associated with administering radiotherapy along with adjuvant cisplatin and topotecan in patients with cervical cancer.
* Determine the feasibility of administering continuous infusion topotecan chemotherapy together with radiation therapy.
* Assess the quality of life of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of topotecan.
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Some patients may also undergo brachytherapy. Patients also receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 and topotecan IV continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Quality of life is assessed at baseline and at 4 and 14 weeks after completion of study treatment.
After completion of study treatment, patients are followed periodically.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combo Chemotherapy and Radiation
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Some patients may also undergo brachytherapy. Patients also receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 and topotecan IV continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
cisplatin
intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36
topotecan hydrochloride
intravenously continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36 -Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined
brachytherapy
Some patients may also undergo brachytherapy
radiation therapy
once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36
Interventions
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cisplatin
intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36
topotecan hydrochloride
intravenously continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36 -Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined
brachytherapy
Some patients may also undergo brachytherapy
radiation therapy
once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Deemed not curable by surgery or radiotherapy alone
* The following stages are eligible:
* Stage IIB
* Stage IIIA or IIIB
* Stage IVA
* Stage IB or IIA with ≥ 1 of the following risk factors:
* Primary tumor ≥ 6 cm
* Positive pelvic and/or para-aortic lymph nodes (resected or unresected)
* Positive surgical margins
* Depth of invasion \> 50% and positive capillary-lymphatic space involvement
* The following histologic subtypes are eligible:
* Squamous
* Adenosquamous
* Adenocarcinoma
* No recurrent cervical cancer
* Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
* White blood cells (WBC) ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Granulocyte count ≥ 1,500/mm\^3
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 1.5 times institutional normal
* Serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase ≤ 3 times institutional normal
* No other prior or concurrent malignancies other than skin (excluding melanoma)
* No septicemia, severe infection, gastrointestinal bleeding, or intestinal obstruction
* No anatomic abnormalities (e.g., pelvic kidney or renal transplant) requiring modification of radiation fields
* Fertile patients must use effective contraception
* Negative pregnancy test
* Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) are eligible if disease is stable for the past 6 months
* Recovered from recent surgery
Exclusion Criteria
* Pregnant or nursing
* History of thrombus
* History of unstable angina or myocardial infarction within the past 6 months
18 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Linda F. Carson, MD
Role: STUDY_CHAIR
Masonic Cancer Center, University of Minnesota
Locations
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University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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UMN-2001LS041
Identifier Type: OTHER
Identifier Source: secondary_id
UMN-WCC-34
Identifier Type: OTHER
Identifier Source: secondary_id
104864/638
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000452043
Identifier Type: -
Identifier Source: org_study_id