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

NCT00955240 | Terminated Phase 2 DMC

• 4 other identifiers: CDR0000642638FRE-FNCLCC-ACCORD-16-0708EU-209412007-007029-38
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 20

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.

Conditions

Anal Cancer

Keywords

stage II anal cancer; stage IIIA anal cancer; stage IIIB anal cancer; squamous cell carcinoma of the anus

Outcome Measures

Primary Outcomes (1)

• Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment

Secondary Outcomes (3)

• Survival rate at 3 and 5 years

• Colostomy-free survival at 3 and 5 years

• Duration of objective response

Interventions

cetuximab BIOLOGICAL

cisplatin DRUG

fluorouracil DRUG

laboratory biomarker analysis OTHER

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed anal cancer * Squamous cell disease * Locally advanced, non-metastatic disease * One of the following clinical TNM stages: * T2, N0, M0 (largest diameter ≥ 3 cm) * T3-T4, N0, M0 * Any T, N1-N3, M0 * No undifferentiated small cell carcinoma or adenocarcinoma * Measurable disease according to RECIST criteria * Undergone endorectal ultrasound or MRI to evaluate the primary tumor * Undergone thoraco-abdomino-pelvic scan to evaluate tumor extension * Disease suitable to receive radiotherapy and chemotherapy PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Leukocytes ≥ 4,000/mm\^3 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Creatinine clearance \> 60 mL/min * ALT and AST ≤ 5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Total bilirubin ≤ 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * No history of cancer within the past 8 years except for in situ cervical cancer or previously treated basal cell carcinoma of the skin * No contraindications to any component of study therapy * No serious uncontrolled illness * No symptomatic grade 1 angina pectoris or angina pectoris ≥ grade 2 * No congestive heart failure * No peripheral sensory neuropathy * No uncontrolled diabetes * No HIV positivity * No geographical, social, or psychological situations that preclude medical follow up * Affiliated with a social security system * No patient deprived of liberty or under trusteeship PRIOR CONCURRENT THERAPY: * Patients with a diverting colostomy are eligible * 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

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

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (20)

Institut Bergonie

Bordeaux, 33076, France

Location

CHU Hopital A. Morvan

Brest, 29609, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

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

Montpellier, 34298, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Tenon

Paris, 75970, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Centre Hospitalier Prive Saint-Gregoire

Saint-Grégoire, 35768, France

Location

Clinique Du Parc

Toulouse, 31078, France

Location

Groupe Oncorad Garonne

Toulouse, 31300, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Cetuximab; Cisplatin; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal 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; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Eric Deutsch, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 10, 2009
• Study Start: March 1, 2009
• Primary Completion: November 26, 2010
• Study Completion: November 26, 2010
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

FR (20)