Clinical trial NCT00598156: Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva
Official title: Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2008-01-18
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
measure: progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Vejle Hospital, Department of Oncology
city: Esbjerg
country: Denmark
facility: Esbjerg Hospital
city: Herning
country: Denmark
facility: Herning Hospital
city: Hillerod
country: Denmark
facility: Hillerod Hospital, Department of Oncology
city: Odense
country: Denmark
facility: Odense Hospital, Department of Oncology
city: Roskilde
country: Denmark
facility: Roskilde Hospital, Department of Oncology
city: Jonkoping
country: Sweden
facility: Ryhov Hospital, Department of Oncology
city: Kalmar
country: Sweden
facility: Kalmar Hospital, Department of Oncology
city: Lund
country: Sweden
facility: Lund University Hospital, Department of Oncology
city: Malmo
country: Sweden
facility: University Hospital MAS
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Department of Oncology
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital, Department of Oncology
city: Umeå
country: Sweden
facility: University Hospital of Norrland, Department of Oncology
city: Uppsala
country: Sweden
facility: Akademiska Hospital, Department of Oncology
city: Vaxjo
country: Sweden
facility: Vaxjo Hospital, Department of Oncology
Study officials:
affiliation: Lund University Hospital, Sweden
name: Anders Johnsson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.