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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598156
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : April 22, 2013
Hoffmann-La Roche
Information provided by (Responsible Party):
Lund University Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: erlotinib (Tarceva) Drug: bevacizumab (Avastin) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.
Study Start Date : June 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)
Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

Drug: bevacizumab (Avastin)
Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

Experimental: 2
bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab every third week until progression
Drug: bevacizumab (Avastin)
Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00598156

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, Sweden, 22185
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
Sponsors and Collaborators
Lund University Hospital
Hoffmann-La Roche
Principal Investigator: Anders Johnsson, MD PhD Lund University Hospital, Sweden

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lund University Hospital Identifier: NCT00598156     History of Changes
Other Study ID Numbers: ML19033
EUDRACT 2006-002295-18
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: April 22, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Erlotinib Hydrochloride
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action