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Colorectal CancerPhase 2NCT00628810

Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

A Phase 2 study testing bevacizumab, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 32 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy 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 bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Colorectal Cancer
What is being tested?
bevacizumab, fluorouracil and irinotecan hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
32 sitesFrance
Study dates
Jan 2007to Dec 2008
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 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 times normal
Show all 10Show fewer
  • Alkaline phosphatase ≤ 2.5 times normal (5 times normal if liver involvement)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients of must use effective contraception

Who cannot join

  • Progressive gastrointestinal ulcer, hemorrhagic ulcer, or perforation in the past 6 months
  • Enteropathy or chronic diarrhea
  • Proteinuria > 500 mg/24 hours
  • Active cardiac disease
  • Uncontrolled hypertension
  • Myocardial infarction in the past 12 months
Show all 28Show fewer
  • Angina
  • NYHA grade II-IV congestive heart disease
  • Severe arrhythmia even with treatment
  • Peripheral vascular disease ≥ grade II
  • Nonhealing wound, ulcer, or severe bone fracture
  • Hemorrhagic diatheses or coagulopathy
  • Severe or uncontrolled infection
  • Severe or uncontrolled medical condition
  • Other malignant disease in the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the uterine cervix
  • Severe traumatic injury within the past 4 weeks
  • PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy for metastatic disease
  • One prior regimen of chemotherapy in the neoadjuvant or adjuvant setting for the original tumor allowed
  • At least 6 months since prior chemotherapy
  • No prior irinotecan hydrochloride or bevacizumab
  • No oral or parenteral anticoagulant therapy within the past 10 days
  • Warfarin allowed provided INR < 1.5
  • No major surgery or biopsy within the past 4 weeks
  • No puncture in the past 7 days
  • No planned major surgery
  • No concurrent daily or chronic aspirin (> 325 mg/day), anti-inflammatories, or steroids
  • No other concurrent anticancer therapy

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

France32 sites

  • Centre Hospitalier d'Abbeville

    Abbeville, 80101

  • Centre Hospitalier Universitaire d'Amiens

    Amiens, 80054

  • Hopital Duffaut

    Avignon, 84902

  • C.H.G. Beauvais

    Beauvais, 60021

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Hopital Ambroise Pare

    Boulogne-Billancourt, F-92104

  • Centre Hospitalier Pierre Oudot

    Bourgoin, 38300

  • Centre Hospitalier General

    Brivé, 19101

  • CHU de Caen

    Caen, 14033

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier de Chalons-en-Champagne

    Châlons-en-Champagne, 51000

  • Hopitaux Civils de Colmar

    Colmar, 68024

  • Hopital Du Bocage

    Dijon, 21034

  • Federation Francophone de Cancerologie Digestive

    Dijon, 21079

  • Clinique Saint Vincent

    Épernay, 51200

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • Centre Hospitalier Universitaire de Bicetre

    Le Kremlin-Bicêtre, 94275

  • CHU de la Timone

    Marseille, 13385

  • CHU Nord

    Marseille, 13915

  • Hopital de l'Archet CHU de Nice

    Nice, F-06202

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45100

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • CHU - Robert Debre

    Reims, 51092

  • Hopital Charles Nicolle

    Rouen, 76031

  • Clinique Mathilde

    Rouen, 76100

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • CHRU de Tours - Hopital Trousseau

    Tours, 37044

  • Centre Hospitalier General Lucien Hussel

    Vienne, 38200

  • Clinique du Tonkin

    Villeurbanne, 69100

Other trials in France

About this study

Official title: Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study

RATIONALE: Drugs used in chemotherapy 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 bevacizumab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with metastatic colorectal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the objective response (RECIST criteria) at 6 months associated with FOLFIRI and bevacizumab therapy.
  • Evaluate the tolerability (NCI CTC v. 2.0 criteria) of this treatment.

Secondary

  • Evaluate progression-free survival and overall survival.
  • Determine the time to treatment failure.
  • Evaluate the quality of life (EuroQOL EQ5D questionnaire).
  • Explore the prognostic factors associated with the tolerability and efficacy of this treatment.

OUTLINE: This is a multicenter study. Patients are stratified according to genotype (UCT1A1*1/ UCT1A1*1 vs UCT1A1*1/ UCT1A1*28).

Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 4 courses, and then every 2 months after the completion of study therapy.

After completion of study therapy, patients are followed every 2-3 months.

Keywords
adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

Study groups in NCT00628810
Study groupRoleWhat they receive
FOLFIRI fort plus bevacizumabExperimentalBevacizumab 5 mg/kg D1, irinotecan 260 mg/m2 D1, LV 400 mg/m2 D1, 5FU 400 mg/m2 IV bolus D1, and 5FU 2,400 mg/m2 46-hour infusion D1-2 every 2 weeks. Treatment was started within 2 weeks after inclusion in the study.
Receives: Biological: bevacizumab; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

What is being measured

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

  1. Objective response at 6 months by RECIST

    Measured: 6 months

  2. Tolerability evaluated by NCI CTC v. 2.0 criteria

    Measured: From Inclusion

Secondary outcomes (3)

  1. Progression-free and overall survival

    Measured: From Inclusion

  2. Time to treatment failure

    Measured: From Inclusion

  3. Quality of life using the EuroQOL EQ5D questionnaire

    Measured: From Inclusion

Timeline

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

  1. First posted5 Mar 2008 (estimated)
  2. Study startJan 2007
  3. Primary completionJan 2008
  4. Study completionDec 2008

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
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00628810
Sponsor's protocol ID
CDR0000564065
Other IDs
FFCD-0504, EUDRACT-2006-003157-25, EU-20755
Status last verified
Nov 2020
First submitted
4 Mar 2008
Last updated
9 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • Manfredi S, Bouche O, Rougier P, Dahan L, Loriot MA, Aparicio T, Etienne PL, Lafargue JP, Lecaille C, Legoux JL, Le Malicot K, Maillard E, Lecomte T, Khemissa F, Breysacher G, Michel P, Mitry E, Bedenne L. High-Dose FOLFIRI plus Bevacizumab in the Treatment of Metastatic Colorectal Cancer Patients with Two Different UGT1A1 Genotypes: FFCD 0504 Study. Mol Cancer Ther. 2015 Dec;14(12):2782-8. doi: 10.1158/1535-7163.MCT-15-0293. Epub 2015 Oct 22.

    PubMed 26494856

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 32 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?

The sponsor lists 10 inclusion and 28 exclusion criteria. 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: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 at 6 months by RECIST (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT00628810, which also lists 1 linked publication.

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 9 Nov 2020.

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