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

NCT ID: NCT00101192

Last Updated: 2014-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30

Brief 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.

Detailed 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.

Conditions

Cervical Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cetuximab

Intervention Type: BIOLOGICAL

cisplatin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John H. Farley, MD

Role: STUDY_CHAIR

Uniformed Services University of the Health Sciences

Locations

Providence Saint Joseph Medical Center - Burbank

Burbank, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, United States

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Christus Schumpert Cancer Treatment Center

Shreveport, Louisiana, United States

University of Mississippi Cancer Clinic

Jackson, Mississippi, United States

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Voorhees Township, New Jersey, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Cancer Care Associates - Midtown Tulsa

Tulsa, Oklahoma, United States

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, United States

University of Texas Medical Branch

Galveston, Texas, United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Countries

United States

References

Farley J, Sill MW, Birrer M, Walker J, Schilder RJ, Thigpen JT, Coleman RL, Miller BE, Rose PG, Lankes HA. Phase II study of cisplatin plus cetuximab in advanced, recurrent, and previously treated cancers of the cervix and evaluation of epidermal growth factor receptor immunohistochemical expression: a Gynecologic Oncology Group study. Gynecol Oncol. 2011 May 1;121(2):303-8. doi: 10.1016/j.ygyno.2011.01.030. Epub 2011 Feb 16.

Reference Type: RESULT

PMID: 21329967 (View on PubMed)

Other Identifiers

BMS-CA225-075

Identifier Type: -

Identifier Source: secondary_id

CDR0000405839

Identifier Type: -

Identifier Source: secondary_id

GOG-0076DD

Identifier Type: -

Identifier Source: org_study_id