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

Metastatic Colorectal Cancer Clinical Trial

— ACT  

Official title:

Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598156
• Other study ID #: ML19033
• Secondary ID: EUDRACT 2006-002
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2008
• Last updated: April 19, 2013
• Start date: June 2007
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: August 2012
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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

Locations

Country	Name	City	State
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
Sweden	Ryhov Hospital, Department of Oncology	Jonkoping
Sweden	Kalmar Hospital, Department of Oncology	Kalmar
Sweden	Lund University Hospital, Department of Oncology	Lund
Sweden	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

Sponsors (2)

Lead Sponsor	Collaborator
Lund University Hospital	Hoffmann-La Roche

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		3 years	Yes
Secondary	overall survival		3 years	No