Feasibility Study of Weekly IV Topotecan and Cisplatin With Concurrent Pelvic Radiation in the Treatment of Stages IB2 - IVA Cervical Carcinoma
Inclusion Criteria:
1. 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.
2. Patients with negative, non-suspicious para-aortic nodes determined by
lymphangiogram, CT, MRI or lymphadenectomy.
3. 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.
4. Patients with adequate renal function: Creatinine equal to or less than 1.5 mg%.
5. 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.
6. Patients who have signed an approved informed consent.
7. Patients with GOG Performance Status of 0, 1, 2, or 3.
8. Patients of childbearing potential must have a negative serum pregnancy test and use
an effective form of contraception.
9. Patients who are suitable for treatment with radical intent using concurrent
cisplatin and pelvic radiation.
Exclusion Criteria:
1. Patients who cannot be or have not been adequately clinically staged.
2. Patients with lower one-third vaginal involvement.
3. Patients with septicemia or severe infection.
4. Patients with circumstances that will not permit completion of the study or required
follow-up.
5. 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.
6. Patients with carcinoma of the cervical stump.
7. Patients who are lactating or pregnant.