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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101192
• Other study ID #: GOG-0076DD
• Secondary ID: BMS-CA225-075CDR
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2005
• Last updated: February 3, 2014
• Start date: September 2004

Study information

• Verified date: February 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Biological:
• cetuximab

Drug:
• cisplatin

Locations

Country	Name	City	State
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	University of Texas Medical Branch	Galveston	Texas
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Oklahoma University Cancer Institute	Oklahoma City	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	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	Christus Schumpert Cancer Treatment Center	Shreveport	Louisiana
United States	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma
United States	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	Bristol-Myers Squibb, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 f — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response	Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria: Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.; Partial Response(PR): at least a 30% decrease in the sum of longest dimensions(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions.; Increasing Disease: at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.; Stable Disease: any condition not meeting the above criteria.; Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.	up to 6 months from study entry	No
Secondary	Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment		up to 5 years from study entry	No