Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma

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 staging criteria.

Primary Objective:

Feasibility and toxicity of administering weekly Topotecan among patients with carcinoma of the cervix receiving concurrent pelvic radiation and Cisplatin.

Secondary Objective(s):

To assess the efficacy of administering weekly Topotecan to patients with carcinoma of the cervix receiving concurrent pelvic radiation and Cisplatin on:

• progression-free survival,
• overall survival, and
• local control

Statistic This is a feasibility study. A two phase accrual will be utilized. If none or 1 of the 6 patients in the first Stage of accrual finish the prescribed therapy in over 8 weeks, then the second Stage of accrual (an additional 6 patients) will increase the Topotecan dose to 3 mg//m2 on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles). If 2 or 3 of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, the dose of the Topotecan will remain the same in the second Phase of accrual. If 4 or more of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, there will be no second phase of accrual.

Inclusion criteria

• 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 criteria

• 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.