Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This phase I trial is studying the side effects and best dose of cetuximab when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving cetuximab together with cisplatin and radiation therapy may kill more tumor cells.

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

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cetuximab; Cisplatin

Criteria

Inclusion Criteria:

• Histologically confirmed cervical cancer

• Clinical stage IB-IVA disease

• Any cell type allowed

• Positive or negative pelvic and/or para-aortic lymph nodes by radiography

• Unstained sections from primary tumor available

• Performance status - GOG 0-1

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• SGOT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• Creatinine normal

• Creatinine clearance > 50 mL/min

• Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry

• No renal abnormality (e.g., pelvic kidney or horseshoe kidney) that would require modification of radiation fields

• No significant cardiac disease within the past 6 months, including any of the following:

• Uncontrolled hypertension

• Unstable angina

• Congestive heart failure

• Uncontrolled arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No sensory or motor neuropathy > grade 1

• No septicemia

• No severe infection

• No circumstance that would preclude study participation or follow-up

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

• No uncontrolled seizure disorder

• No active neurologic disease

• No history of active collagen vascular disease

• No prior chimerized or murine monoclonal antibody therapy

• No prior cytotoxic chemotherapy for cervical cancer

• No prior pelvic or abdominal radiotherapy for cervical cancer

• No concurrent intensity modulated radiotherapy

• No prior renal transplantation

• More than 30 days since prior major surgery (excluding diagnostic biopsy)

• No other prior therapy for cervical cancer

• No prior cancer treatment that would preclude study therapy

• No other concurrent investigational agents