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Phase I Study of Pelvic or Pelvic Radiotherapy, Cisplatin, and Topotecan in Patients With Locally Advanced Cervical Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
Basic Trial Information
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Protocol IDs
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Phase I
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Treatment
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Active
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Not specified
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NCI
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GOG-9913
NCT00054444, GOG-9913
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Objectives Primary - Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer.
- Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population.
Secondary - Determine the site of recurrence (local vs distant) in patients treated with this regimen.
Entry Criteria Disease Characteristics:
- Histologically confirmed primary invasive carcinoma of the uterine cervix
- Stages IB2, II, IIIB, and IVA disease
- Any cell type
- No known metastasis to scalene nodes or organs outside the radiation field
- No known intraperitoneal metastases
- No evidence of extrapelvic disease based on negative CT or PET scan
- Must enroll within 8 weeks of diagnosis
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - No prior chemotherapy for any prior malignancy
- No prior cytotoxic chemotherapy for this malignancy
Endocrine therapy Radiotherapy - No prior radiotherapy for any prior malignancy
- No prior pelvic or abdominal radiotherapy for this malignancy
Surgery - See Patient Characteristics- Renal
Other - No prior therapy for this malignancy
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
Renal - Creatinine normal
OR - Creatinine clearance > 50 mL/min
- Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed
- No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields
Other - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No septicemia or severe infection
- No other medical or psychiatric condition that would preclude study compliance
Expected Enrollment 60A total of 30 patients will be accrued for this study. Outline This is a multicenter, dose-escalation study of topotecan. Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks 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 at which 1 of 6 patients experiences dose-limiting toxicity. Once the MTD is determined, an additional cohort of 20 patients receives treatment as above at the MTD. After completion of study treatment, patients are followed periodically for 5 years.
Trial Contact Information
Trial Lead Organizations Gynecologic Oncology Group | | | | Peter Rose, MD, Protocol chair | | | |
Trial Sites
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| U.S.A. |
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| Illinois |
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Chicago |
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| | | | | | | | | University of Chicago Cancer Research Center |
| | | Clinical Trials Office - University of Chicago Cancer Research Center | |
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| Iowa |
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Iowa City |
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| | | | Holden Comprehensive Cancer Center at University of Iowa |
| | | Cancer Information Service | |
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| New Jersey |
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Voorhees |
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| | | | Cancer Institute of New Jersey at Cooper - Voorhees |
| | | Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees | |
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| Ohio |
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Cleveland |
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| | | | MetroHealth Cancer Care Center at MetroHealth Medical Center |
| | | Peter Rose, MD | |
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Columbus |
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| | | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center |
| | | Clinical Trials Office - OSU Comprehensive Cancer Center | |
| | Email:
osu@emergingmed.com |
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| Oklahoma |
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Oklahoma City |
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| | | | Oklahoma University Cancer Institute |
| | | Robert Mannel, MD | |
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Tulsa |
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| | | Cancer Care Associates - Saint Francis Campus |
| | | Robert Mannel, MD | |
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| Registry Information | | | Official Title | | A Phase I Study Of Pelvic Radiation Therapy With Concomitant Cisplatin And Weekly Topotecan (IND# 58,13) Chemotherapy In Patients With Cervical Carcinoma And Paraortic Nodal Metastasis As The Only Evidence Of Extrapelvic Disease | | | Trial Start Date | | 2007-09-10 | | | Trial Completion Date | | 2008-09-04 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00054444 | | | Date Submitted to PDQ | | 2002-12-23 | | | Information Last Verified | | 2008-09-03 | | | NCI Grant/Contract Number | | CA27469 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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