Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer

NCT ID: NCT00955240

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-11-26

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and 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. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.

Detailed Description

OBJECTIVES:

Primary

• Evaluate the objective response (complete and partial) 8 weeks after completion of study treatment comprising radiotherapy, chemotherapy (fluorouracil and cisplatin), and cetuximab followed by additional radiotherapy in patients with locally advanced anal cancer.

Secondary

• Evaluate colostomy-free survival.
• Evaluate the local control rate (objective response and stabilization) at 8 weeks.
• Evaluate relapse-free survival at 5 years.
• Evaluate the intermediate objective response at the end of week 5 of radiotherapy.
• Evaluate overall survival at 5 years.
• Evaluate the duration of response.
• Evaluate acute toxicities according to CTCAE v3.0.
• Evaluate late toxicities at 5 years according to CTCAE v3.0.
• Study the tumor markers associated with response (survival without relapse) and toxicity.
• Study the genotypes of Fc-receptor immunoglobulins (FCGR2A and FCGR3) and their association with skin toxicity, objective survival, and relapse-free survival.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV on days 0, 7, 14, 21, 28, and 35; fluorouracil IV on days 7-10 and 35-38; and cisplatin IV over 2 hours on days 7 and 35. Beginning on day 7, patients also undergo radiotherapy 5 days a week for 5 weeks (weeks 2-6). Two weeks after finishing this treatment, patients undergo additional radiotherapy* 5 days a week for 2 weeks (weeks 9 and 10).

NOTE: *Some patients may undergo brachytherapy.

Blood and tissue samples are collected for further analysis.

After completion of study treatment, patients are followed up for 4 years.

Conditions

Anal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cetuximab

Intervention Type: BIOLOGICAL

cisplatin

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

laboratory biomarker analysis

Intervention Type: OTHER

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• No prior excision of this tumor
• No prior chemotherapy or radiotherapy for the treatment of this cancer or any other history of radiotherapy or pelvic brachytherapy
• No concurrent coumarin anticoagulants, phenytoin, sorivudine or brivudine, antacids, or allopurinol
• Not registered in another clinical trial with an experimental drug

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Deutsch, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Institut Bergonie

Bordeaux, , France

CHU Hopital A. Morvan

Brest, , France

Centre Regional Francois Baclesse

Caen, , France

Centre Hospitalier Departemental

La Roche-sur-Yon, , France

Centre Oscar Lambret

Lille, , France

Centre Hospital Regional Universitaire de Limoges

Limoges, , France

Centre Leon Berard

Lyon, , France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, , France

Centre Antoine Lacassagne

Nice, , France

Institut Curie Hopital

Paris, , France

Hopital Saint-Louis

Paris, , France

Hopital Tenon

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Hopital Charles Nicolle

Rouen, , France

Centre Hospitalier Prive Saint-Gregoire

Saint-Grégoire, , France

Clinique Du Parc

Toulouse, , France

Groupe Oncorad Garonne

Toulouse, , France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

FRE-FNCLCC-ACCORD-16-0708

Identifier Type: OTHER

Identifier Source: secondary_id

EU-20941

Identifier Type: OTHER

Identifier Source: secondary_id

2007-007029-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDR0000642638

Identifier Type: -

Identifier Source: org_study_id