Status:
COMPLETED
Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
There will be approximately 14,000 new patients with invasive cervical cancer diagnosed in the United States in 2003 with about 4,000 deaths from this disease. This accounts for approximately 17% of a...
Detailed Description
All eligible patients with invasive squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix, Stages I-B2, II-B, III-B, and IV-A, will experience clinical staging as permitted by FIGO s...
Eligibility Criteria
Inclusion
- Patients with primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, Stage I-2, II-B, III-B, IV-A.
- Patients with negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT, MRI or lymphadenectomy.
- Patients with adequate bone marrow function: ANC greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl, and Hemoglobin \> 10 mg/dl.
- Patients with adequate renal function: Creatinine equal to or less than 1.5 mg%.
- Patients with adequate hepatic function: Bilirubin less than or equal to 1.5 x normal and SGOT and Alkaline phosphatase less than or equal to 3 x normal.
- Patients who have signed an approved informed consent.
- Patients with GOG Performance Status of 0, 1, 2, or 3.
- Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.
- Patients who are suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation.
Exclusion
- Patients who cannot be or have not been adequately clinically staged.
- Patients with lower one-third vaginal involvement.
- Patients with septicemia or severe infection.
- Patients with circumstances that will not permit completion of the study or required follow-up.
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
- Patients with carcinoma of the cervical stump.
- Patients who are lactating or pregnant.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00257816
Start Date
January 1 2004
End Date
December 17 2007
Last Update
February 5 2018
Active Locations (1)
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1
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868