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

NCT00598156 | Completed Phase 3 DMC

• 2 other identifiers: ML19033EUDRACT 2006-002295-18
• Study Type: interventional
• Target: 249
• Locations: 2 countries
• Sites: 15

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).

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  3 years

Secondary Outcomes (1)

• overall survival

  3 years

Study Arms (2)

1

EXPERIMENTAL

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)

2

EXPERIMENTAL

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

Drug: bevacizumab (Avastin)

Interventions

erlotinib (Tarceva) DRUG

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

1

bevacizumab (Avastin) DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lund University Hospital: lead
• Hoffmann-La Roche: collaborator

Study Sites (15)

Vejle Hospital, Department of Oncology

Copenhagen, Denmark

Location

Esbjerg Hospital

Esbjerg, Denmark

Location

Herning Hospital

Herning, Denmark

Location

Hillerod Hospital, Department of Oncology

Hillerød, Denmark

Location

Odense Hospital, Department of Oncology

Odense, Denmark

Location

Roskilde Hospital, Department of Oncology

Roskilde, Denmark

Location

Ryhov Hospital, Department of Oncology

Jönköping, Sweden

Location

Kalmar Hospital, Department of Oncology

Kalmar, Sweden

Location

Lund University Hospital, Department of Oncology

Lund, 22185, Sweden

Location

University Hospital MAS

Malmo, Sweden

Location

Karolinska University Hospital, Department of Oncology

Stockholm, Sweden

Location

Sundsvall Hospital, Department of Oncology

Sundsvall, Sweden

Location

University Hospital of Norrland, Department of Oncology

Umeå, Sweden

Location

Akademiska Hospital, Department of Oncology

Uppsala, Sweden

Location

Vaxjo Hospital, Department of Oncology

Vaxjo, Sweden

Location

Related Publications (2)

• 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.

  PMID: 23922111 DERIVED

• 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.

  PMID: 23788755 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Erlotinib Hydrochloride; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Anders Johnsson, MD PhD

  Lund University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: June 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: August 1, 2012
• Last Updated: April 22, 2013

Record last verified: 2013-04

Locations

DK (6); SE (9)