Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to the radiation. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel when given with radiation therapy and cisplatin and to see how well they work in treating patients with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven previously untreated invasive carcinoma of the uterine cervix

• Squamous cell carcinoma

• Adenosquamous carcinoma

• Adenocarcinoma

• TNM classification stage IIIB or IVA (FIGO classification stage IB, IIA, IIB, IIIA, IIIB, or IVA)

• Cytologically or histologically proven metastases to the para-aortic lymph nodes

• No more than 8 weeks since diagnosis

• No metastases to scalene nodes, intraperitoneal metastases, or metastases to other organs outside the radiation field at the time of original clinical and surgical staging

• Negative CT scan of the chest

• Patients with ureteral obstruction must be treated with stent or nephrostomy tube

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• At least 6 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times normal

• SGOT no greater than 3 times normal

Renal:

• Creatinine less than 2.0 mg/dL

• No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) requiring modification of radiation fields

Other:

• Not pregnant

• No septicemia or severe infection

• No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior cytotoxic chemotherapy for this or other malignancy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for this or other malignancy

• No prior radiotherapy to pelvis or abdomen

Surgery:

• Not specified

Other:

• No other prior therapy for this malignancy