Colorectal CancerPhase 2NCT01181609

A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

A Phase 2 study testing bevacizumab [Avastin] in people with Colorectal Cancer, run by Hoffmann-La Roche at 16 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

This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: bevacizumab [Avastin]
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 16 sitesFrance
Study dates: Jun 2005to May 2010
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
Women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.

Who cannot join

Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
Untreated brain metastases, spinal cord compression or primary brain tumours;
Pregnant or lactating women;
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start;
Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

France16 sites

Study site
Angers, 49933
Study site
Besançon, 25030
Study site
Boulogne-Billancourt, 92104
Study site
Colmar, 68024
Study site
Dijon, 21079
Study site
La Roche-sur-Yon, 85925
Study site
Marseille, 13005
Study site
Montpellier, 34298
Study site
Neuilly-sur-Seine, 92200
Study site
Nice, 06189
Study site
Paris, 75679
Study site
Pierre-Bénite, 69310
Study site
Reims, 51092
Study site
Saint-Cloud, 92210
Study site
Saint-Herblain, 44805
Study site
Toulouse, 31052

Other trials in France

About this study

Official title: An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer

Conditions: Colorectal Cancer
Being tested: bevacizumab [Avastin]
Medical subject headings: Colorectal Neoplasms

What participants receive

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

bevacizumab [Avastin]Drug
5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to the chemotherapy regimen

Study groups in NCT01181609
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: bevacizumab [Avastin]

What is being measured

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

Percentage of Participants Achieving Overall Disease Control (ODC)
ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.
Measured: Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)

Secondary outcomes (7)

Percentage of Participants Achieving a Best Overall Response of CR or PR
Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.
Measured: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
Progression-Free Survival (PFS) - Percentage of Participants With an Event
PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST.
Measured: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
PFS - Time to Event
PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. Median PFS was estimed using the Kaplan-Meier method.
Measured: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
Duration of Response
Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method.
Measured: Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up)
Duration of Overall Disease Control
ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method.
Measured: Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up)
Overall Survival (OS) - Percentage of Participants With an Event
Overall survival was defined as the time from start of study treatment to death from any cause.
Measured: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
OS - Time to Event
OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method.
Measured: Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up)

Timeline

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

Jun 2005May 2010

First posted13 Aug 2010 (estimated)
Study startJun 2005
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01181609
Sponsor's protocol ID: ML18559
Status last verified: Jul 2014
First submitted: 30 Jul 2010
Last updated: 28 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer
ClinicalTrials.gov ID: NCT01181609
Acronym / sponsor ID: ML18559
Conditions: Colorectal Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jun 2005
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 13 Aug 2010 (estimated)
Results: Posted 28 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: bevacizumab [Avastin]

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
Women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.

Key exclusion criteria (5 listed)

Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
Untreated brain metastases, spinal cord compression or primary brain tumours;
Pregnant or lactating women;
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start;
Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bevacizumab [Avastin]5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to the chemotherapy regimen	Drug	1

Primary outcome

Percentage of Participants Achieving Overall Disease Control (ODC)
Time frame: Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)
ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.

7 secondary outcomes

Percentage of Participants Achieving a Best Overall Response of CR or PR
Time frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
Progression-Free Survival (PFS) - Percentage of Participants With an Event
Time frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
PFS - Time to Event
Time frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
Duration of Response
Time frame: Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up)
Duration of Overall Disease Control
Time frame: Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up)
Overall Survival (OS) - Percentage of Participants With an Event
Time frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
OS - Time to Event
Time frame: Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up)

Results and safety

Results posted to the registry on 28 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bevacizumab + Chemotherapy	54	1

Primary outcome: Percentage of Participants Achieving Overall Disease Control (ODC)

Time frame: Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Bevacizumab + Chemotherapy n = 53
Value	87 (77 to 97)

Population analysed: ITT population

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bevacizumab + Chemotherapy	9 of 53 (17%)	52 of 53 (98.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study chair

Hoffmann-La Roche

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab [Avastin] in people with Colorectal Cancer, run by Hoffmann-La Roche at 16 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 2 inclusion and 5 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 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

Yes. Results are posted in the registry (first posted 28 Jul 2014). 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 Achieving Overall Disease Control (ODC) (time frame: Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)). 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 NCT01181609.

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 28 Jul 2014.