Clinical trial NCT00101192: Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: 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
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Bristol-Myers Squibb
First posted: 2005-01-10
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tumor Response
timeFrame: up to 6 months from study entry
Secondary outcomes:
measure: Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment
timeFrame: up to 5 years from study entry
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center - Burbank
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Savannah
country: United States
facility: Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Kansas City
country: United States
facility: Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Cancer Institute at Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Christus Schumpert Cancer Treatment Center
state: Louisiana
city: Jackson
country: United States
facility: University of Mississippi Cancer Clinic
state: Mississippi
city: Voorhees
country: United States
facility: Fox Chase Virtua Health Cancer Program at Virtua West Jersey
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Cancer Care Center at MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Cancer Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates - Midtown Tulsa
state: Oklahoma
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
city: Reading
country: United States
facility: McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: M. D. Anderson Cancer Center at University of Texas
state: Texas
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: John H. Farley, MD
role: STUDY_CHAIR
References:
citation: 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.