Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

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

Summary

RATIONALE: 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. Cetuximab may also help cisplatin work better by making tumor cells more sensitive to the drug. 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. Giving cetuximab together with cisplatin may be a better way to block tumor growth.

PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborators: Bristol-Myers Squibb; National Cancer Institute (NCI)
• Treatments: Cetuximab; Cisplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous or non-squamous cell carcinoma of the cervix

• Advanced, persistent, or recurrent disease

• Documented disease progression

• Not amenable to curative therapy

• Measurable disease

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• At least 1 target lesion

• Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy to confirm persistence

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Platelet count ≥ 100,000/mm^3

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

Hepatic

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

• AST ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

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

• Unstable angina

• Uncontrolled hypertension

• Uncontrolled congestive heart failure

• Uncontrolled arrhythmia

Neurologic

• No uncontrolled seizure disorder

• No active neurological disease

• No neuropathy (sensory and motor) > grade 1

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection requiring antibiotics

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior anti-epidermal growth factor receptor (EGFR) antibody therapy

• No prior chimerized or murine monoclonal antibody therapy

Chemotherapy

• Not specified

Endocrine therapy

• At least 1 week since prior anticancer hormonal therapy

• Concurrent hormone replacement therapy allowed

Radiotherapy

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

Surgery

• More than 30 days since prior major surgery, except diagnostic biopsy

Other

• Recovered from all prior therapy

• No prior cytotoxic therapy for cervical cancer

• No prior tyrosine kinase inhibitor therapy that targets the EGFR pathway

• No prior cancer treatment that would contraindicate study therapy

• No other concurrent investigational agents