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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
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Drug: erlotinib (Tarceva)
Drug: bevacizumab (Avastin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 249
Study Start Date: June 2007
Study Completion Date: August 2012
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598156

Locations
Denmark
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
Sweden
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
Investigators
Principal Investigator: Anders Johnsson, MD PhD Lund University Hospital Sweden
  More Information

No publications provided by Lund University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT00598156     History of Changes
Other Study ID Numbers: ML19033, EUDRACT 2006-002295-18
Study First Received: January 9, 2008
Last Updated: April 19, 2013
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on November 27, 2014