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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00598156
First received: January 9, 2008
Last updated: April 19, 2013
Last verified: April 2013

January 9, 2008
April 19, 2013
June 2007
October 2009   (final data collection date for primary outcome measure)
progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
progressionfree survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00598156 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Colorectal Cancer
  • Drug: erlotinib (Tarceva)
    Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)
  • Drug: bevacizumab (Avastin)
    Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)
  • Experimental: 1
    bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression
    Interventions:
    • 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
    Intervention: Drug: bevacizumab (Avastin)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
August 2012
October 2009   (final data collection date for primary outcome measure)

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:

  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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Sweden
 
NCT00598156
ML19033, EUDRACT 2006-002295-18
Yes
Lund University Hospital
Lund University Hospital
Hoffmann-La Roche
Principal Investigator: Anders Johnsson, MD PhD Lund University Hospital Sweden
Lund University Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP