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CompletedNCT00598156ACTUpdated Apr 22, 2013

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

A Phase 3 interventional study of erlotinib (Tarceva) and bevacizumab (Avastin) in Metastatic Colorectal Cancer, sponsored by Lund University Hospital. Completed at 15 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-22.

Sponsored by Lund University Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
249
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Metastatic Colorectal Cancer
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 249 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Lund University Hospital is the lead sponsor of 64 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
249 participants (actual)

Study arms

  • Experimental
    1

    bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression

    Drug: erlotinib (Tarceva) · Drug: bevacizumab (Avastin)

  • Experimental
    2

    bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab every third week until progression

    Drug: bevacizumab (Avastin)

Interventions

  • Drugerlotinib (Tarceva)

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

  • Drugbevacizumab (Avastin)

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

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What researchers measure

Primary outcomes

  1. progression-free survival

    Time frame: 3 years

Secondary outcomes

  1. overall survival

    Time frame: 3 years

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Study locations

15 sites
  • Vejle Hospital, Department of Oncology
    Copenhagen, Denmark
  • Esbjerg Hospital
    Esbjerg, Denmark
  • Herning Hospital
    Herning, Denmark
  • Hillerod Hospital, Department of Oncology
    Hillerod, Denmark
  • Odense Hospital, Department of Oncology
    Odense, Denmark
  • Roskilde Hospital, Department of Oncology
    Roskilde, Denmark
  • Ryhov Hospital, Department of Oncology
    Jonkoping, Sweden
  • Kalmar Hospital, Department of Oncology
    Kalmar, Sweden
  • Lund University Hospital, Department of Oncology
    Lund, 22185, Sweden
  • University Hospital MAS
    Malmo, Sweden
  • Karolinska University Hospital, Department of Oncology
    Stockholm, Sweden
  • Sundsvall Hospital, Department of Oncology
    Sundsvall, Sweden
  • University Hospital of Norrland, Department of Oncology
    Umeå, Sweden
  • Akademiska Hospital, Department of Oncology
    Uppsala, Sweden
  • Vaxjo Hospital, Department of Oncology
    Vaxjo, Sweden
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00598156
Lead sponsor
Lund University Hospital
Collaborators
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jan 18, 2008
Start date
Jun 2007
Primary completion
Oct 2009
Completion
Aug 2012
Last update
Apr 22, 2013

Study contacts

Anders Johnsson, MD PhD
principal investigator · Lund University Hospital, Sweden

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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