Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage IB, Stage II, or Stage IIIB Cervical Cancer

NCT00957411 | Completed Phase 2

• 3 other identifiers: CDR0000651250CLCC-IC-2007-042008-001053-18
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. 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. It is not yet known whether radiation therapy given together with cisplatin is more effective with or without cetuximab in treating patients with cervical cancer. PURPOSE: This randomized phase II trial is studying giving radiation therapy together with cisplatin to see how well it works compared with radiation therapy and cisplatin given together with cetuximab in treating patients with stage IB, stage II, or stage IIIB cervical cancer.

Conditions

Cervical Cancer

Keywords

stage IB cervical cancer; stage IIA cervical cancer; stage IIB cervical cancer; stage III cervical cancer; cervical adenocarcinoma; cervical squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival at 2 years

Secondary Outcomes (2)

• Response as assessed by MRI after radiochemotherapy and before surgery according to RECIST criteria

• Toxicity according to NCI CTCAE v3.0

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients receive cisplatin IV over 1 hour once weekly during weeks 1-6. Patients also undergo pelvic radiotherapy 5 days a week during weeks 2-5 or 2-6.

Drug: cisplatin

Arm II

EXPERIMENTAL

Patients receive cisplatin and undergo radiotherapy as in arm I. Patients also receive cetuximab IV over 1 hour once weekly during weeks 1-6.

Biological: cetuximab; Drug: cisplatin

Interventions

cetuximab BIOLOGICAL

Given IV

Arm II

cisplatin DRUG

Given IV

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of cervical cancer * Squamous cell carcinoma or adenocarcinoma * Stage IB2-IIIB disease * Not immediately operable * Origin of the tumor and presence of measurable target lesion according to RECIST criteria confirmed by T2-weighted MRI * Data imaging scan and PET scan (optional) confirmed absence of lumbo-aortic adenopathy * No other associated pathology that would preclude study treatment PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Hemoglobin \> 10 g/dL * ANC \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Alkaline phosphatase \< 2 times normal * Total bilirubin \< 1.5 times normal * Creatinine \< 130 μmol/L * Creatinine clearance ≥ 60 mL/min * Normal vital functions * Not pregnant * Fertile patients must use effective contraception * Able to provide the imaging exams on CD ROM (DICOM 3.0 or higher) for centralized review * No history of another cancer that recurred within the past 5 years except for basal cell carcinoma of the skin or carcinoma in situ of the cervix * No absolute contraindication to MRI (i.e., claustrophobia, pacemaker, or cochlear implant) * No geographical, social, or psychological situations that preclude study follow up * Not deprived of liberty or under guardianship * Receiving benefits from a social security system PRIOR CONCURRENT THERAPY: * No prior treatment (i.e., chemotherapy, radiotherapy, immunotherapy, hormonal therapy, or, especially, therapy with an investigational agent) for this cancer * No concurrent participation in a clinical trial with an experimental agent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie Hopital

Paris, 75248, France

Location

Related Publications (1)

• de la Rochefordiere A, Kamal M, Floquet A, Thomas L, Petrow P, Petit T, Pop M, Fabbro M, Kerr C, Joly F, Sevin E, Maillard S, Cure H, Weber B, Brunaud C, Minsat M, Gonzague L, Berton-Rigaud D, Aumont M, Gladieff L, Peignaux K, Bernard V, Leroy Q, Bieche I, Margogne A, Nadan A, Fourchotte V, Diallo A, Asselain B, Plancher C, Armanet S, Beuzeboc P, Scholl SM. PIK3CA Pathway Mutations Predictive of Poor Response Following Standard Radiochemotherapy +/- Cetuximab in Cervical Cancer Patients. Clin Cancer Res. 2015 Jun 1;21(11):2530-7. doi: 10.1158/1078-0432.CCR-14-2368. Epub 2015 Feb 27.

  PMID: 25724520 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

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)

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

• Susan Scholl, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: March 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: October 1, 2014
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (1)