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Anal CancerPhase 2NCT00955240

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

A Phase 2 study testing cetuximab, cisplatin and fluorouracil in people with Anal Cancer, run by UNICANCER at 20 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Anal Cancer
What is being tested?
cetuximab, cisplatin and fluorouracil
Type of treatment
Surgery or procedure
How many people
16 participants
Where
20 sitesFrance
Study dates
Mar 2009to 26 Nov 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • Institut Bergonie

    Bordeaux, 33076

  • CHU Hopital A. Morvan

    Brest, 29609

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69373

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

    Montpellier, 34298

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie Hopital

    Paris, 75248

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Tenon

    Paris, 75970

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital Charles Nicolle

    Rouen, 76031

  • Centre Hospitalier Prive Saint-Gregoire

    Saint-Grégoire, 35768

  • Clinique Du Parc

    Toulouse, 31078

  • Groupe Oncorad Garonne

    Toulouse, 31300

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

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

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.

Read the 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
Being tested
cetuximab, cisplatin, fluorouracil, laboratory biomarker analysis, radiation therapy
Keywords
stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, squamous cell carcinoma of the anus
Medical subject headings
Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

  1. Survival rate at 3 and 5 years

  2. Colostomy-free survival at 3 and 5 years

  3. Duration of objective response

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2009 (estimated)
  2. Study startMar 2009
  3. Primary completion26 Nov 2010
  4. Study completion26 Nov 2010

Why it stopped: Inadequate toxicity

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00955240
Sponsor's protocol ID
CDR0000642638
Other IDs
FRE-FNCLCC-ACCORD-16-0708, EU-20941, 2007-007029-38
Status last verified
Feb 2020
First submitted
7 Aug 2009
Last updated
11 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab, cisplatin and fluorouracil in people with Anal Cancer, run by UNICANCER at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Inadequate toxicity). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00955240.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.

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