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Colorectal CancerPhase 2NCT00423696

Bevacizumab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

A Phase 2 study testing bevacizumab, capecitabine and fluorouracil in people with Colorectal Cancer, run by UNICANCER at 15 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: 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
bevacizumab, capecitabine and fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
15 sitesFrance
Study dates
23 Mar 2006to 1 Aug 2011
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal cancer
  • Unresectable metastatic disease
  • Measurable disease
  • No CNS metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Life expectancy > 3 months
  • Absolute neutrophil count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin > 9 g/dL (transfusion allowed)
  • INR < 1.5
  • Alkaline phosphatase < 1.5 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • AST and ALT < 2.5 times ULN (5 times ULN if liver metastases are present)
  • Creatinine clearance > 30 mL/min
  • Urine protein < 2+ OR ≤ 1 g/L by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No contraindications to study therapy
  • No gastrointestinal or duodenal ulcers
  • No AIDS
  • No serious illness, active infection, or other serious condition that would preclude study therapy
  • No coagulation problem
  • No bleeding diathesis
  • No sensitivity to Chinese hamster ovarian cells or other recombinant human antibodies
  • No severe renal insufficiency
  • No uncontrolled hypertension
  • No active or severe cardiovascular conditions, including the following:
  • Cerebrovascular accident
  • Myocardial infarction within the past 6 months
  • New York Heart Association class II-IV cardiac insufficiency
  • Severe cardiac arrhythmia (even if treated)
  • No primitive stenosis or symptomatic peritoneal carcinosis causing a risk of intestinal subocclusion or occlusion
  • No nonhealing wound or fracture
  • No prior thromboembolic disease
  • No other cancer within the past 2 years except for basal cell skin cancer or carcinoma in situ of the uterine cervix
  • No geographical, social, or psychological condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for metastatic disease
  • At least 6 months since prior adjuvant chemotherapy (fluorouracil with or without oxaliplatin)
  • No prior adjuvant chemotherapy comprising irinotecan hydrochloride with or without bevacizumab
  • At least 28 days since prior major surgery
  • Prior radiotherapy allowed except to target lesions
  • At least 10 days since prior anticoagulants
  • No concurrent chronic acetylsalicylic acid (at doses > 325 mg/day)
  • No other concurrent investigational therapy
  • No other concurrent anticancer therapy

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • C.H.U. de Brest

    Brest, 29200

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • Polyclinique des Quatre Pavillons

    Lormont, 33310

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

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

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie Hopital

    Paris, 75248

  • Polyclinique Francheville

    Périgueux, 24004

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35062

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

Official title: Phase II Randomized Study of First-Line Therapy Comprising Bevacizumab and Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil (FOLFIRI) Versus Bevacizumab and Irinotecan Hydrochloride and Capecitabine (XELIRI) in Patients With Unresectable Metastatic Colorectal Cancer [ACCORD]

RATIONALE: 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 colorectal cancer by blocking blood flow to the tumor. 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. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with bevacizumab in treating patients with colorectal cancer.

PURPOSE: This randomized phase II trial is studying bevacizumab to compare how well it works when given together with two different combination chemotherapy regimens as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the progression-free survival at 6 months in patients with unresectable metastatic colorectal cancer treated with first-line therapy comprising bevacizumab and irinotecan hydrochloride, leucovorin calcium, and fluorouracil (FOLFIRI) vs bevacizumab and irinotecan hydrochloride and capecitabine (XELIRI).

Secondary

  • Compare the toxicities of these regimens in these patients.
  • Compare the objective response rate and duration of response in patients treated with these regimens.
  • Compare the tumor control in patients treated with these regimens.
  • Compare the progression-free and overall survival of patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0 or 1 vs 2), age (< 65 years vs ≥ 65 years), and number of metastatic sites (1 vs ≥ 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive bevacizumab alone every 2 weeks in the absence of disease progression.
  • Arm II: Patients receive bevacizumab IV over 30-90 minutes and irinotecan hydrochloride IV over 90 minutes on day 1 and oral capecitabine on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive bevacizumab alone every 3 weeks in the absence of disease progression.

Quality of life is assessed periodically.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.

Keywords
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 NCT00423696
Study groupRoleWhat they receive
bevacizumab + FOLFIRIExperimentalNot described
Receives: Biological: bevacizumab; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium
bevacizumab + XELIRIExperimentalNot described
Receives: Biological: bevacizumab; Drug: capecitabine; Drug: irinotecan hydrochloride

What is being measured

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

  1. Progression-free survival at 6 months

Secondary outcomes (7)

  1. Percentage of objective responses

  2. Percentage of stable disease responses

  3. Duration of objective response and stable disease

  4. Progression-free survival

  5. Overall survival

  6. Toxicities

  7. Quality of life

Timeline

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

  1. First posted18 Jan 2007 (estimated)
  2. Study start23 Mar 2006
  3. Primary completion28 Jul 2008
  4. Study completion1 Aug 2011

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00423696
Sponsor's protocol ID
CDR0000523435
Other IDs
FRE-FNCLCC-ACCORD-13-0503, EU-20666, 2005-000070-43, 2005
Status last verified
Feb 2021
First submitted
16 Jan 2007
Last updated
17 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Malka D, Boige V, Jacques N, Vimond N, Adenis A, Boucher E, Pierga JY, Conroy T, Chauffert B, Francois E, Guichard P, Galais MP, Cvitkovic F, Ducreux M, Farace F. Clinical value of circulating endothelial cell levels in metastatic colorectal cancer patients treated with first-line chemotherapy and bevacizumab. Ann Oncol. 2012 Apr;23(4):919-27. doi: 10.1093/annonc/mdr365. Epub 2011 Aug 8.

    PubMed 21825101

  • Antoun S, Bayar MA, Dyevre V, Lanoy E, Smolenschi C, Ducreux M. No evidence for changes in skeletal muscle mass or weight during first-line chemotherapy for metastatic colorectal cancer. BMC Cancer. 2019 Aug 28;19(1):847. doi: 10.1186/s12885-019-6086-2.

    PubMed 31462288

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, capecitabine and fluorouracil in people with Colorectal Cancer, run by UNICANCER at 15 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: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

Progression-free survival at 6 months. 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 NCT00423696, which also lists 2 linked publications.

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 17 Feb 2021.

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