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

Gynecologic Oncology Group (GOG)

Status and phase

Completed

Phase 2

Conditions

Cervical Cancer

Treatments

Drug: cisplatin

Biological: cetuximab

Study type

Interventional

Funder types

NETWORK

Industry

NIH

Identifiers

NCT00101192

GOG-0076DD

BMS-CA225-075

CDR0000405839

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

Determine the antitumor activity of cetuximab and cisplatin, in terms of objective tumor response (partial and complete), in patients with advanced, persistent, or recurrent carcinoma of the cervix.
Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

Determine the progression-free survival and overall survival of patients treated with this regimen.
Correlate epidermal growth factor receptor expression with progression-free survival, overall survival, and response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and cisplatin IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.

Enrollment

76 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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