AzTrials
AzTrials

Metastatic Colorectal CancerPhase 3ACTNCT00598156

Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva

A Phase 3 study testing erlotinib (Tarceva) and bevacizumab (Avastin) in people with Metastatic Colorectal Cancer, run by Lund University Hospital at 15 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

Chemotherapy and bevacizumab is given for 4 months. Patients who have not progressed will continue with maintenance treatment with either bevacizumab (Avastin) alone, or bevacizumab and erlotinib (Tarceva). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
erlotinib (Tarceva) and bevacizumab (Avastin)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
249 participants
Where
15 sitesin 2 countries
Study dates
Jun 2007to Aug 2012
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

Who may be able to join

  • Adenocarcinoma of the colon or rectum.
  • Age > 18.
  • Measurable disease according to RECIST criteria.
  • Expected survival more than three months.
  • Adequate bone marrow, liver and kidney function.
  • INR < 1.5 times upper limit.
  • Adequate contraception for fertile patients.
  • Signed written informed consent.

Who cannot join

  • Earlier chemotherapy for metastatic colorectal cancer.
  • Adjuvant treatment within 6 months.
  • Surgery or significant trauma within 28 days prior to study entry.
  • Planned radiotherapy against target lesions.
  • CNS metastases.
  • Prior malignancy within 5 years except ca in situ of cervix and basal cell carcinoma.
Show all 12Show fewer
  • Bleeding diathesis
  • Uncontrolled hypertension.
  • Significant cardiovascular disease.
  • Treatment with anticoagulant drugs.
  • Participation in other clinical trial.
  • Pregnant or lactating.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

Sweden9 sites

  • Ryhov Hospital, Department of Oncology

    Jönköping

  • Kalmar Hospital, Department of Oncology

    Kalmar

  • Lund University Hospital, Department of Oncology

    Lund, 22185

  • University Hospital MAS

    Malmö

  • Karolinska University Hospital, Department of Oncology

    Stockholm

  • Sundsvall Hospital, Department of Oncology

    Sundsvall

  • University Hospital of Norrland, Department of Oncology

    Umeå

  • Akademiska Hospital, Department of Oncology

    Uppsala

  • Vaxjo Hospital, Department of Oncology

    Vaxjo

Other trials in Sweden

Denmark6 sites

  • Vejle Hospital, Department of Oncology

    Copenhagen

  • Esbjerg Hospital

    Esbjerg

  • Herning Hospital

    Herning

  • Hillerod Hospital, Department of Oncology

    Hillerød

  • Odense Hospital, Department of Oncology

    Odense

  • Roskilde Hospital, Department of Oncology

    Roskilde

Other trials in Denmark

About this study

Official title: Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.

Chemotherapy and bevacizumab is given for 4 months. Patients who have not progressed will continue with maintenance treatment with either bevacizumab (Avastin) alone, or bevacizumab and erlotinib (Tarceva).

Read the detailed description

Patients with metastatic colorectal cancer will be treated with standard chemotherapy according to the investigators choice. In addition to chemotherapy, Avastin (bevacizumab) will be given during the treatment period. After the chemotherapy is finished (after 18 weeks), maintenance therapy will be given and the patients will be randomized to treatment with either with Avastin alone or Avastin in combination with Tarceva (erlotinib). Patients with progressive disease, or patients suitable to curative resection of metastases will be taken out of study.

Being tested
erlotinib (Tarceva), 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.

  • erlotinib (Tarceva)Drug

    Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

  • bevacizumab (Avastin)Drug

    Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

Study groups in NCT00598156
Study groupRoleWhat they receive
1Experimentalbevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression
Receives: Drug: erlotinib (Tarceva); Drug: bevacizumab (Avastin)
2Experimentalbevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab every third week until progression
Receives: Drug: bevacizumab (Avastin)

What is being measured

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

  1. progression-free survival

    Measured: 3 years

Secondary outcomes (1)

  1. overall survival

    Measured: 3 years

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 2008 (estimated)
  2. Study startJun 2007
  3. Primary completionOct 2009
  4. Study completionAug 2012

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
249 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00598156
Sponsor's protocol ID
ML19033
Other IDs
EUDRACT 2006-002295-18
Acronym
ACT
Status last verified
Apr 2013
First submitted
9 Jan 2008
Last updated
22 Apr 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Hansen TF, Christensen Rd, Andersen RF, Sorensen FB, Johnsson A, Jakobsen A. MicroRNA-126 and epidermal growth factor-like domain 7-an angiogenic couple of importance in metastatic colorectal cancer. Results from the Nordic ACT trial. Br J Cancer. 2013 Sep 3;109(5):1243-51. doi: 10.1038/bjc.2013.448. Epub 2013 Aug 6.

    PubMed 23922111

  • Johnsson A, Hagman H, Frodin JE, Berglund A, Keldsen N, Fernebro E, Sundberg J, De Pont Christensen R, Garm Spindler KL, Bergstrom D, Jakobsen A. A randomized phase III trial on maintenance treatment with bevacizumab alone or in combination with erlotinib after chemotherapy and bevacizumab in metastatic colorectal cancer: the Nordic ACT Trial. Ann Oncol. 2013 Sep;24(9):2335-41. doi: 10.1093/annonc/mdt236. Epub 2013 Jun 19.

    PubMed 23788755

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing erlotinib (Tarceva) and bevacizumab (Avastin) in people with Metastatic Colorectal Cancer, run by Lund University Hospital at 15 sites in 2 countries.

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 8 inclusion and 12 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 22 Apr 2013. 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 Sweden, Denmark. 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 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 (time frame: 3 years). 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 NCT00598156, 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 22 Apr 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in