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

NCT00104910 | Completed Phase 1

• 4 other identifiers: GOG-9918NCI-2009-00621CDR0000413880U10CA027469
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) or biologically effective dose (BED) of Cetuximab in combination with cisplatin and extended field radiation or whole pelvis radiation, graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)

  Evaluation of the regimens will be conducted separately by the type of radiation received (extended field radiation or whole pelvis radiation).

  6 weeks

• Incidence of toxicities at the MTD, assessed by CTCAE v3.0

  Up to 1 year

Secondary Outcomes (3)

• Progression-free survival

  From study entry until disease progression, death or date of last contact, up to 1 year

• Site of recurrence, loco-regional vs distant, assessed by clinical and radiological evaluation

  From study entry until disease progression, death or date of last contact, up to 1 year

• Frequency of chronic toxicities, assessed by CTCAE v3.0

  From study entry until disease progression, death or date of last contact, up to 1 year

Study Arms (1)

Treatment (brachytherapy, radiation, cetuximab, cisplatin)

EXPERIMENTAL

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.

Radiation: Internal Radiation Therapy; Radiation: 3-Dimensional Conformal Radiation Therapy; Biological: Cetuximab; Drug: Cisplatin

Interventions

Internal Radiation Therapy RADIATION

Also known as: Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

Treatment (brachytherapy, radiation, cetuximab, cisplatin)

3-Dimensional Conformal Radiation Therapy RADIATION

Also known as: 3D-CRT, Conformal Therapy, Radiation Conformal Therapy

Treatment (brachytherapy, radiation, cetuximab, cisplatin)

Cetuximab BIOLOGICAL

Given IV

Also known as: Chimeric MoAb C225, Erbitux, IMC-C225

Treatment (brachytherapy, radiation, cetuximab, cisplatin)

Cisplatin DRUG

Given IV

Treatment (brachytherapy, radiation, cetuximab, cisplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

Georgia Regents University Medical Center

Augusta, Georgia, 30912, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Brachytherapy; Radiotherapy, Conformal; Cetuximab; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Radiotherapy, Computer-Assisted; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Kathleen Moore

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: January 1, 2005
• Primary Completion: January 1, 2013
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

US (15)