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

Primary Purpose

Anal Cancer

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
cetuximab
cisplatin
fluorouracil
laboratory biomarker analysis
radiation therapy
Sponsored by
UNICANCER
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Cancer focused on measuring stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, squamous cell carcinoma of the anus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Bergonie
  • CHU Hopital A. Morvan
  • Centre Regional Francois Baclesse
  • Centre Hospitalier Departemental
  • Centre Oscar Lambret
  • Centre Hospital Regional Universitaire de Limoges
  • Centre Leon Berard
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Regional Rene Gauducheau
  • Centre Antoine Lacassagne
  • Institut Curie Hopital
  • Hopital Saint-Louis
  • Hopital Tenon
  • Centre Hospitalier Lyon Sud
  • Hopital Charles Nicolle
  • Centre Hospitalier Prive Saint-Gregoire
  • Clinique Du Parc
  • Groupe Oncorad Garonne
  • Centre Alexis Vautrin
  • Institut Gustave Roussy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival rate at 3 and 5 years
Colostomy-free survival at 3 and 5 years
Duration of objective response

Full Information

First Posted
August 7, 2009
Last Updated
February 7, 2020
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00955240
Brief Title
Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer
Official Title
Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Inadequate toxicity
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 26, 2010 (Actual)
Study Completion Date
November 26, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer
Keywords
stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, squamous cell carcinoma of the anus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
cetuximab
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment
Secondary Outcome Measure Information:
Title
Survival rate at 3 and 5 years
Title
Colostomy-free survival at 3 and 5 years
Title
Duration of objective response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Deutsch, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Hopital A. Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Hospitalier Departemental
City
La Roche Sur Yon
ZIP/Postal Code
F-85025
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Hospitalier Prive Saint-Gregoire
City
Saint-Gregoire
ZIP/Postal Code
35768
Country
France
Facility Name
Clinique Du Parc
City
Toulouse
ZIP/Postal Code
31078
Country
France
Facility Name
Groupe Oncorad Garonne
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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