Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Brief Summary

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This phase I trial is studying the side effects and best dose of cetuximab when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer. 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. 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. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving cetuximab together with cisplatin and radiation therapy may kill more tumor cells.

Detailed Description

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PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose or safe biologically effective dose of cetuximab when administered in combination with cisplatin, external beam radiotherapy, and brachytherapy in patients with stage IB-IVA cervical cancer.

II. Determine the feasibility of this regimen, in terms of chronic and acute toxic effects, in these patients.

SECONDARY OBJECTIVES:

I. Determine the distribution of progression-free survival and overall survival of patients treated with this regimen at 1 year after study entry.

II. Determine the site of recurrence (locoregional vs distant) in patients treated with this regimen up to 1 year after study entry.

III. Correlate response or progression-free survival with epidermal growth factor receptor expression in tumor samples from patients treated with this regimen at 1 year after study entry.

IV. Correlate response or progression-free survival with grade of cetuximab-induced rash in patients treated with this regimen at 1 year after study entry.

OUTLINE: This is a multicenter, dose-escalation study of cetuximab. Patients are stratified according to nodal status (positive para-aortic and/or pelvic lymph nodes vs negative para-aortic and pelvic lymph nodes).

Patients receive cetuximab IV over 1-2 hours and cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). Patients also undergo external beam radiotherapy to the para-aortic and pelvic lymph nodes OR whole pelvis once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33 (weeks 1-5). Patients then receive either 1 or 2 applications of low-dose rate brachytherapy in weeks 6-8 OR 5 applications of high-dose rate (HDR)\* brachytherapy once weekly in weeks 4-8. Treatment continues in the absence of disease progression or unacceptable toxicity.

NOTE: \*No external beam radiotherapy is administered on the day of HDR brachytherapy. If the majority of external beam radiotherapy has been administered, HDR brachytherapy may be administered in 2 applications per week (separated by at least 72 hours) in order to complete all treatment within 8 weeks.

Cohorts of 3-6 patients per stratum receive escalating doses of cetuximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year.

Conditions

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Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Small Cell Carcinoma Cervical Squamous Cell Carcinoma Stage IB Cervical Cancer Stage IIA Cervical Cancer Stage IIB Cervical Cancer Stage III Cervical Cancer Stage IVA Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (brachytherapy, radiation, cetuximab, cisplatin)

Patients receive cetuximab IV over 1-2 hours and cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). Patients also undergo external beam radiotherapy to the para-aortic and pelvic lymph nodes OR whole pelvis once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33 (weeks 1-5). Patients then receive either 1 or 2 applications of low-dose rate brachytherapy in weeks 6-8 OR 5 applications of high-dose rate (HDR)\* brachytherapy once weekly in weeks 4-8. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Internal Radiation Therapy

Intervention Type RADIATION

3-Dimensional Conformal Radiation Therapy

Intervention Type RADIATION

Cetuximab

Intervention Type BIOLOGICAL

Given IV

Cisplatin

Intervention Type DRUG

Given IV

Interventions

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Internal Radiation Therapy

Intervention Type RADIATION

3-Dimensional Conformal Radiation Therapy

Intervention Type RADIATION

Cetuximab

Given IV

Intervention Type BIOLOGICAL

Cisplatin

Given IV

Intervention Type DRUG

Other Intervention Names

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Brachytherapy Internal Radiation Internal Radiation Brachytherapy Radiation Brachytherapy 3D-CRT Conformal Therapy Radiation Conformal Therapy Chimeric MoAb C225 Erbitux IMC-C225

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed cervical cancer

* Clinical stage IB-IVA disease
* Any cell type allowed
* Positive or negative pelvic and/or para-aortic lymph nodes by radiography
* Unstained sections from primary tumor available
* Performance status - GOG 0-1
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Creatinine normal
* Creatinine clearance \> 50 mL/min
* Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
* No renal abnormality (e.g., pelvic kidney or horseshoe kidney) that would require modification of radiation fields
* No significant cardiac disease within the past 6 months, including any of the following:

* Uncontrolled hypertension
* Unstable angina
* Congestive heart failure
* Uncontrolled arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No sensory or motor neuropathy \> grade 1
* No septicemia
* No severe infection
* No circumstance that would preclude study participation or follow-up
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No uncontrolled seizure disorder
* No active neurologic disease
* No history of active collagen vascular disease
* No prior chimerized or murine monoclonal antibody therapy
* No prior cytotoxic chemotherapy for cervical cancer
* No prior pelvic or abdominal radiotherapy for cervical cancer
* No concurrent intensity modulated radiotherapy
* No prior renal transplantation
* More than 30 days since prior major surgery (excluding diagnostic biopsy)
* No other prior therapy for cervical cancer
* No prior cancer treatment that would preclude study therapy
* No other concurrent investigational agents

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Moore

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

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Georgia Regents University Medical Center

Augusta, Georgia, United States

Site Status

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Lake University Ireland Cancer Center

Mentor, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Women and Infants Hospital

Providence, Rhode Island, United States

Site Status

Parkland Memorial Hospital

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States