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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

Phase 2
18 Years
Not Enrolling
Cervical Cancer

Thank you

Trial Information

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



- 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.


- 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

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

Inclusion Criteria


- 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



- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified


- Platelet count ≥ 100,000/mm^3

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


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

- AST ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN


- Creatinine ≤ 1.5 times ULN


- No significant history of cardiac disease within the past 6 months, including the

- Unstable angina

- Uncontrolled hypertension

- Uncontrolled congestive heart failure

- Uncontrolled arrhythmia


- No uncontrolled seizure disorder

- No active neurological disease

- No neuropathy (sensory and motor) > grade 1


- 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


Biologic therapy

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

- No prior chimerized or murine monoclonal antibody therapy


- Not specified

Endocrine therapy

- At least 1 week since prior anticancer hormonal therapy

- Concurrent hormone replacement therapy allowed


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy


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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity as assessed by RECIST criteria every 4 weeks

Safety Issue:


Principal Investigator

John H. Farley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Uniformed Services University of the Health Sciences


United States: Federal Government

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical small cell carcinoma
  • cervical squamous cell carcinoma
  • stage III cervical cancer
  • stage IVA cervical cancer
  • stage IVB cervical cancer
  • Uterine Cervical Neoplasms



MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
University of Texas Medical Branch Galveston, Texas  77555-1329
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans, Louisiana  70121
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees, New Jersey  08043
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Christus Schumpert Cancer Treatment Center Shreveport, Louisiana  71101