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Colorectal CancerPhase 2OMEGANCT00467142

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, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by Institut Bergonié at 1 site 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 120 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
62 participants
Where
1 siteFrance
Study dates
23 Jan 2007to Dec 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the colon or rectum
  • No other histological types
  • Metastatic, unresectable disease
  • No bone metastases only
  • Unidimensionally measurable metastatic disease
  • No CNS metastases

PATIENT CHARACTERISTICS:

  • WHO performance status (PS) 0-2 OR Karnofsky PS 70-100%
  • Life expectancy ≥ 12 weeks
  • ANC > 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin ≤ 1.25 times normal (1.5 times normal in presence of hepatic metastases)
  • AST and ALT < 3 times normal (5 times normal in presence of hepatic metastases)
  • Creatinine < 1.25 times normal
  • No proteinuria
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other cancer in the past 5 years except for carcinoma in situ of the uterine cervix or basal cell skin cancer
  • No hypersensitivity to fluorouracil
  • No hypersensitivity to leucovorin calcium, bevacizumab, or their excipients
  • No hypersensitivity to Chinese hamster ovarian cell products or other recombinant humanized or nonhumanized monoclonal antibodies
  • No allergy to irinotecan hydrochloride
  • No prior reaction to attenuated vaccines (fever, jaundice)
  • No poor nutritional status
  • No Biermer anemia or other anemia due to vitamin B12 deficiency
  • No uncontrolled symptomatic occlusion or subocclusion
  • No medullary hypoplasia or severe insufficiency
  • No prior chronic intestinal disease
  • No Gilbert's syndrome
  • No intra-abdominal inflammatory reaction (e.g., gastroduodenal ulcer, diverticulitis, or colitis)
  • No chronic intestinal inflammatory disease
  • No thromboembolic arterial condition in the past 6 months, including any of the following:
  • Cardiovascular accident
  • Transient ischemic attack
  • Myocardial infarction
  • No infection or serious noncancerous disease
  • No condition that is unstable or would increase risk to the patient, including any of the following:
  • Unstable angina
  • Poorly controlled hypertension
  • Severe cardiac insufficiency
  • Serious arrhythmia
  • Bleeding diathesis
  • Pulmonary disease at risk of decompensation
  • No familial, geographical, social, or psychological condition that would preclude study participation
  • No prisoners or patients without guardians

PRIOR CONCURRENT THERAPY:

  • At least 8 weeks since prior surgery
  • At least 6 months since prior adjuvant chemotherapy
  • At least 1 month since prior palliative chemotherapy
  • No prior abdominal or pelvic radiotherapy
  • At least 30 days since prior participation in another investigational study
  • No prior bevacizumab
  • No extensive intestinal resection (e.g., partial colectomy or extensive thin resection)
  • No concurrent warfarin, Hypericum perforatum (St. John's wort), or prophylactic phenytoin

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Bergonie

    Bordeaux, 33076

Other trials in France

About this study

Official title: Phase II Study Evaluating the Efficacy and Tolerance to Chemotherapy With 5-fluorouracil, Folinic Acid, Irinotecan and Bevacizumab as First-line Treatment in Patients With Metastatic Colorectal Cancer

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, such as irinotecan, leucovorin, and fluorouracil, 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.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the efficacy of bevacizumab, irinotecan hydrochloride, leucovorin calcium, and fluorouracil, in terms of partial or complete response, in patients with unresectable metastatic colorectal cancer.

Secondary

  • Determine the duration of response in patients treated with this regimen.
  • Determine the overall survival and progression-free survival of patients treated with this regimen.
  • Determine the tolerability of this regimen in these patients.
  • Assess the pharmacogenetics and change in genetic polymorphisms susceptible to modification by this regimen.

OUTLINE: This is a nonrandomized, multicenter study.

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

Blood and tissue samples are collected periodically for pharmacogenetic and genetic polymorphism analysis.

PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.

Keywords
stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, 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 NCT00467142
Study groupRoleWhat they receive
Folfiri and BevacizumabExperimental* Premedication = Dexchlorpheniramine, 5 mg in slow Direct IntraVeinous (DIV) on D1. * FOLFIRI (simplified LV5FU2 + irinotecan): * Irinotecan (Campto®): 180 mg/m² on D1 by IV infusion in 250 mL of 0.9% saline over 90 minutes. * LV5FU2, in its so-called "simplified" version, will be administered as follows L-folinic acid, as a 2-hour intravenous infusion, at a dose of 200 mg/m², on Day 1, in 500 mL of 5% glucose solution, concomitantly with the irinotecan infusion via a Y-tube, followed by 5 Fluorouracil (5 FU), intravenous bolus, at a dose of 400 mg/m² on D1, followed by 5 Fluorouracil (5 FU) as a 46-hour continuous infusion at a dose of 2400 mg/m² from D1 to D3, either in 1000 mL of 5% glucose solution, or in an electric syringe or pump dispenser * Bevacizumab (Avastin®): 5 mg/kg IV infusion in 100 mL of 0.9% saline over 90 minutes for the first infusion, then 60 minutes for the second infusion if tolerated, and 30 minutes for subsequent infusions if tolerated.
Receives: Biological: bevacizumab; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Genetic: polymorphism analysis

What is being measured

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

  1. Percentage of Participants in Objective Response (Partial or Complete Responses)

    Objective response defined as complete or partial responses according to RECIST v1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).Radiologic assessment was carried out every four cycles (8 weeks) with centralized external secondary review.

    Measured: 6 months

Secondary outcomes (1)

  1. Median Duration of Response

    Duration of response is defined as the delay between response (complete or partial) and disease progression according to RECIST V1.0. Therefore, this criterion can only be assessed in in subjects who have responded. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.). Progression is defined as a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, or appearance of one or several new lesions (RECIST V1.0) Radiologic assessment was carried out every four cycles (8 weeks) with centralized external secondary review.

    Measured: 24 months

Timeline

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

  1. First posted27 Apr 2007 (estimated)
  2. Study start23 Jan 2007
  3. Primary completionMay 2010
  4. Study completionDec 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00467142
Sponsor's protocol ID
CDR0000540522
Other IDs
IB-2006-31, IB-OMEGA, INCA-RECF0387, EUDRACT-2006-003901-22
Acronym
OMEGA
Status last verified
Oct 2022
First submitted
25 Apr 2007
Last updated
1 Nov 2022
Data monitoring committee
No

Publications

  • Becouarn Y, Cany L, Pulido M, Beyssac R, Texereau P, Le Morvan V, Bechade D, Brunet R, Aitouferoukh S, Lalet C, Mathoulin-Pelissier S, Fonck M, Robert J. FOLFIRI(R) and bevacizumab in first-line treatment for colorectal cancer patients: safety, efficacy and genetic polymorphisms. BMC Res Notes. 2014 Apr 23;7:260. doi: 10.1186/1756-0500-7-260.

    PubMed 24758527

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 Institut Bergonié at 1 site 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 20 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants in Objective Response (Partial or Complete Responses) (time frame: 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 NCT00467142, 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 1 Nov 2022.

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