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

Last updated: April 19, 2013
Sponsor: Lund University Hospital
Overall Status: Completed

Phase

3

Condition

Colorectal Cancer

Metastatic Cancer

Treatment

N/A

Clinical Study ID

NCT00598156
ML19033
EUDRACT 2006-002295-18
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 249
Study Start date:
June 01, 2007
Estimated Completion Date:
August 31, 2012

Study 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.

Connect with a study center

  • Vejle Hospital, Department of Oncology

    Copenhagen,
    Denmark

    Site Not Available

  • Esbjerg Hospital

    Esbjerg,
    Denmark

    Site Not Available

  • Herning Hospital

    Herning,
    Denmark

    Site Not Available

  • Hillerod Hospital, Department of Oncology

    Hillerod,
    Denmark

    Site Not Available

  • Odense Hospital, Department of Oncology

    Odense,
    Denmark

    Site Not Available

  • Roskilde Hospital, Department of Oncology

    Roskilde,
    Denmark

    Site Not Available

  • Ryhov Hospital, Department of Oncology

    Jonkoping,
    Sweden

    Site Not Available

  • Kalmar Hospital, Department of Oncology

    Kalmar,
    Sweden

    Site Not Available

  • Lund University Hospital, Department of Oncology

    Lund, 22185
    Sweden

    Site Not Available

  • University Hospital MAS

    Malmo,
    Sweden

    Site Not Available

  • Karolinska University Hospital, Department of Oncology

    Stockholm,
    Sweden

    Site Not Available

  • Sundsvall Hospital, Department of Oncology

    Sundsvall,
    Sweden

    Site Not Available

  • University Hospital of Norrland, Department of Oncology

    Umeå,
    Sweden

    Site Not Available

  • University Hospital of Norrland, Department of Oncology

    Umeå,
    Sweden

    Site Not Available

  • Akademiska Hospital, Department of Oncology

    Uppsala,
    Sweden

    Site Not Available

  • Vaxjo Hospital, Department of Oncology

    Vaxjo,
    Sweden

    Site Not Available

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