ACT: Avastin and Chemotherapy followed by Avastin alone or in combination with Tarceva for the treatment of metastatic colorectal cancer - ACT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002295-18-DK

Enrollment

182

Registered

2006-12-13

Start date

2007-01-24

Completion date

Unknown

Last updated

2013-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with previously untreated metastatic colorectal carcinoma

Interventions

Trade Name: Avastin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: bevacizumab CAS Number: 216974-75-3 Other descriptive name: anti-VEGF, rhuMab Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Untreated metastatic colorectal carcinoma Age = 18 years Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST) criteria Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Life expectancy more than 3 months Adequate haematological, renal and liver function Blood sample and paraffin embedded tumour tissue for translational research Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Adjuvant therapy within 6 months Central nervous system (CNS) metastases Clinically significant atherosclerotic vascular disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that maintenance treatment with bevacizumab + erlotinib (treatment A) following 1st line chemo- and anti-angiogenic therapy results in a significant increase in progression-free survival (PFS) compared to maintenance treatment with bevacizumab alone (treatment B);Secondary Objective: Secondary objectives: To evaluate the safety To evaluate the efficacy in terms of overall response and overall survival Translational research for prognostic and treatment predictive markers ;Primary end point(s): To demonstrate that maintenance treatment with bevacizumab + erlotinib (treatment A) following 1st line chemo- and anti-angiogenic therapy results in a significant increase in progression-free survival (PFS) compared to maintenance treatment with bevacizumab alone (treatment B)	—

Measure

Time frame

Main Objective: To demonstrate that maintenance treatment with bevacizumab + erlotinib (treatment A) following 1st line chemo- and anti-angiogenic therapy results in a significant increase in progression-free survival (PFS) compared to maintenance treatment with bevacizumab alone (treatment B);Secondary Objective: Secondary objectives: To evaluate the safety To evaluate the efficacy in terms of overall response and overall survival Translational research for prognostic and treatment predictive markers ;Primary end point(s): To demonstrate that maintenance treatment with bevacizumab + erlotinib (treatment A) following 1st line chemo- and anti-angiogenic therapy results in a significant increase in progression-free survival (PFS) compared to maintenance treatment with bevacizumab alone (treatment B)

—

Countries

Denmark, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026