Phase 2 N=76 Treatment

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

Cervical Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00101192 ↗

Enrolled (actual)

Serious AEs

47.8%

Results posted

Mar 2014

Primary outcome: Primary: Tumor Response — 1; 7; 17; 34 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cetuximab (Biological); cisplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Gynecologic Oncology Group
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Tumor Response	1; 7; 17; 34; 10	—
SECONDARY Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00101192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.