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Colorectal CancerPhase 3NCT00544700

Bevacizumab in Treating Patients Who Have Undergone First-Line Therapy for Metastatic Colorectal Cancer

A Phase 3 study testing bevacizumab and no maintenance in people with Colorectal Cancer, run by Swiss Cancer Institute at 29 sites in Switzerland.

Terminated

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

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 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
bevacizumab and no maintenance
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
29 sitesSwitzerland
Study dates
26 Nov 2007to 12 Dec 2019
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic colorectal cancer
  • Received prior first-line chemotherapy with oral or intravenous fluoropyrimidine alone or in combination with irinotecan or oxaliplatin
  • Chemotherapy must have been given in combination with a standard dose of bevacizumab for 16-24 weeks as part of first-line treatment for metastatic colorectal cancer
  • Stable disease, partial response, or complete response after completion of first-line treatment as documented by abdominal and thoracic CT scan, MRI, or x-ray within the past 21 days
  • No clinical symptoms or history of CNS metastases
  • No imaging required in asymptomatic patients

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Serum creatinine < 2.0 mg/dL or 177 μmol/L
  • Proteinuria < 2+ by urine dipstick OR urine protein ≤ 1 g by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study therapy
  • Must have basic health insurance with a Swiss health insurance company
  • Patients must be compliant and in geographic proximity to allow proper staging and follow-up
  • No medical reason that prohibits further bevacizumab treatment, including any of the following:
  • Uncontrolled hypertension (systolic blood pressure [BP] > 150 mm Hg and/or diastolic BP > 100 mm Hg) or clinically significant (i.e., active) cardiovascular disease
  • Serious non-healing wound, active peptic ulcer, or non-healing bone fracture
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
  • No serious underlying medical condition that, in the judgment of the investigator, could further impair the ability of the patient to participate in the trial (e.g., active autoimmune disease or uncontrolled diabetes)
  • No psychiatric disorder that would preclude patient understanding of study-related topics or giving informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior bevacizumab
  • No prior anti-EGFR treatment (e.g., cetuximab) during first-line therapy
  • No anticipation of concurrent major surgery (e.g., resection) or ablation of metastases
  • No concurrent elective major surgery
  • No concurrent daily aspirin exceeding 325 mg/day or clopidogrel exceeding 75 mg/day
  • Lower doses of the drugs noted above, or non-steroidal anti-inflammatory drugs with activity on platelets and gastric mucosa, or dipyridamole are allowed if given at a stable dose for ≥ 2 weeks prior to study entry
  • No other concurrent experimental drugs or anticancer therapy

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Switzerland29 sites

  • Kantonsspital Aarau

    Aarau, CH-5000

  • Hirslanden Klinik Aarau

    Aarau, CH-5001

  • Kantonsspital Baden

    Baden, CH-5404

  • St. Claraspital AG

    Basel, CH-4016

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

    Bellinzona, 6500

  • Inselspital, Bern

    Bern, CH-3010

  • Spitalzentrum Biel

    Biel, CH-2501

  • Kantonsspital Bruderholz

    Bruderholz, CH-4101

  • Spital Buelach

    Bülach, CH-8180

  • AndreasKlinik Cham Zug

    Cham, CH-6330

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Hopital Fribourgeois

    Fribourg, 1708

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital Liestal

    Liestal, CH-4410

  • Istituto Oncologico della Svizzera Italiana

    Lugano, CH-6900

  • Kantonsspital Luzern

    Luzerne, CH-6000

  • Onkologie Zentrum am Spital Maennedorf

    Männedorf, 8708

  • Kantonsspital Olten

    Olten, CH-4600

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Hopital Regional de Sion-Herens-Conthey

    Sion, CH -1951

  • Regionalspital

    Thun, 3600

  • Spital Uster

    Uster, 8610

  • Kantonsspital Winterthur

    Winterthur, CH-8400

  • Onkozentrum Klinik im Park

    Zurich, 8038

  • Klinik Hirslanden

    Zurich, CH-8008

  • Stadtspital Waid

    Zurich, CH-8037

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: Bevacizumab Maintenance Versus no Maintenance After Stop of First-line Chemotherapy in Patients With Metastatic Colorectal Cancer. A Randomized Multicenter Phase III Non-inferiority Trial

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 tumor cells by blocking blood flow to the tumor. It is not yet known whether giving bevacizumab as maintenance therapy is more effective than observation in treating patients with colorectal cancer.

PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works in treating patients who have undergone first-line therapy for metastatic colorectal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To demonstrate that time to progression (TTP) without further treatment is not inferior to TTP with maintenance therapy comprising bevacizumab in patients with metastatic colorectal cancer and stable or responding disease after completion of standard first-line chemotherapy/bevacizumab treatment.

Secondary

  • To evaluate the safety of bevacizumab maintenance therapy in these patients.
  • To assess the long-term cost implications of prolonged treatment with bevacizumab.

OUTLINE: This is a multicenter study. Patients are stratified according to best response during first-line chemotherapy/bevacizumab treatment (complete response and partial response vs stable disease), duration of first-line treatment (16-20 weeks vs 21-24 weeks), type of chemotherapy used during first-line treatment (irinotecan and fluoropyrimidine vs oxaliplatin and fluoropyrimidine vs fluoropyrimidine monotherapy), disease burden (one organ with metastasis vs more than one organ with metastasis), and by participating center.

  • Arm I (bevacizumab maintenance therapy): Patients receive bevacizumab IV over 30 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II (no maintenance therapy): Patients receive no further treatment; they are monitored for disease progression.

After completion of study therapy or documentation of disease progression, patients are followed every 3 months for 1 year and then every 6 months for up to 5 years.

Being tested
bevacizumab, no maintenance
Keywords
stage IV colon cancer, stage IV 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.

  • bevacizumabBiological

    Also called Avastin®

    7.5 mg/kg i.v. bevacizumab every 21 days until progression or unacceptable toxicity

  • no maintenanceOther

    No treatment until progression

Study groups in NCT00544700
Study groupRoleWhat they receive
Arm A: Bevacizumab monotherapyActive comparatorBevacizumab maintenance monotherapy
Receives: Biological: bevacizumab
Arm B: No maintenanceOtherNo antitumor treatment until progression
Receives: Other: no maintenance

What is being measured

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

  1. Time to progression (TTP)

    TTP will be calculated from randomization until documented PD or death due to tumor.

    Measured: From randomization until documented progressive disease or death due to tumor.

Secondary outcomes (4)

  1. Overall survival (OS)

    OS will be calculated from start of first-line treatment until death. Additionally, OS will be calculated from randomization until death.

    Measured: OS will be calculated from start of first-line treatment until death. Additionally, OS will be calculated from randomization until death.

  2. Progression-free survival (PFS)

    PFS will be calculated from start of first-line treatment until documented PD or death, whichever occurs first. Additionally, PFS will be calculated from randomization until documented PD or death, whichever occurs first.

    Measured: From start of first-line treatment until documented PD or death, whichever occurs first.

  3. Adverse events (AE)

    Predefined AEs and AEs ≥ grade 3 will be assessed according to NCI CTCAE v3.0.

    Measured: Predefined AEs and AEs ≥ grade 3 will be assessed according to NCI CTCAE v3.0.

  4. Long-term bevacizumab treatment costs

    Costs of bevacizumab treatment, including additional treatments and/or hospitalisations related to bevacizumab, as well as other anticancer treatments and their related hospitalisations, will be estimated for the time period between randomization and the end of the follow-up phase (lasting maximal 5 years) from information collected on the CRFs during trial treatment and follow-up phase.

    Measured: Estimated for the time period between randomization and the end of the follow-up phase (lasting maximal 5 years).

Timeline

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

  1. First posted16 Oct 2007 (estimated)
  2. Study start26 Nov 2007
  3. Primary completion21 Jan 2013
  4. Study completion12 Dec 2019

Why it stopped: Data collection is completed. As no changes in the endpoints were expected in the future, no further data is needed.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00544700
Sponsor's protocol ID
SAKK 41/06
Other IDs
SWS-SAKK-41/06, EU-20762, CDR0000569866
Status last verified
Feb 2020
First submitted
13 Oct 2007
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Koeberle D, Betticher DC, von Moos R, Dietrich D, Brauchli P, Baertschi D, Matter K, Winterhalder R, Borner M, Anchisi S, Moosmann P, Kollar A, Saletti P, Roth A, Frueh M, Kueng M, Popescu RA, Schacher S, Hess V, Herrmann R. Bevacizumab continuation versus no continuation after first-line chemotherapy plus bevacizumab in patients with metastatic colorectal cancer: a randomized phase III non-inferiority trial (SAKK 41/06). Ann Oncol. 2015 Apr;26(4):709-714. doi: 10.1093/annonc/mdv011. Epub 2015 Jan 20.

    PubMed 25605741

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bevacizumab and no maintenance in people with Colorectal Cancer, run by Swiss Cancer Institute at 29 sites in Switzerland.

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 20 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 29 sites in Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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: Data collection is completed. As no changes in the endpoints were expected in the future, no further data is needed.). 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?

Time to progression (TTP) (time frame: From randomization until documented progressive disease or death due to tumor.). 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 NCT00544700, 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 20 Feb 2020.

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