A Limited Access Phase II Trial of Cetuximab (C225, NSC #714692) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

Inclusion 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