Status:
COMPLETED
Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as topotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiati...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of topotecan when administered with cisplatin in patients with advanced cervical cancer. * Identify any unique toxicities associated with administer...
Eligibility Criteria
Inclusion
- Histologically confirmed cervical carcinoma
- 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
- Prior pelvic radiation
- Pregnant or nursing
- History of thrombus
- History of unstable angina or myocardial infarction within the past 6 months
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00287911
Start Date
February 1 2005
End Date
December 1 2009
Last Update
December 2 2017
Active Locations (1)
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1
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455