Avastin and chemotherapy followed by a KRAS stratified randomization to maintenance treatment for first line treatment of metastatic colorectal cancer

Avastin and chemotherapy followed by a KRAS stratified randomization to maintenance treatment for first line treatment of metastatic colorectal cancer - ACT2

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019815-40-SE

Enrollment

230

Registered

2010-07-01

Start date

2010-09-17

Completion date

Unknown

Last updated

2012-03-20

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. MedDRA version: 14.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Avastin Product Name: Avastin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentration unit: mg/ml milligram(s)/mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Untreated metastatic colorectal carcinoma. 2. Age 18 years or more. 3. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 5. Life expectancy more than 3 months. 6. Adequate haematological, renal and liver function. 7. Tumor tissue available for determination of KRAS mutational status. 8. Blood sample and paraffin embedded tumor 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130

Exclusion criteria

Exclusion criteria: 1. Adjuvant therapy within 6 months. 2. Central nervous system (CNS) metastases. 3. Clinically significant atherosclerotic vascular disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression-free survival (PFS) rate at 3 months among patients without KRAS mutation as compared to maintenance treatment with bevacizumab alone.;Secondary Objective: To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumours. To evaluate the efficacy in terms of progression free and overall survival. To perform translational research for prognostic and treatment predictive markers.;Primary end point(s): To evaluate maintenance treatment with bevacizumab+erlotinib versus bevacizumab alone in patients with KRAS WT tumors following first line chemo- and anti-angiogenetic therapy by comparing progression-free survival rate at 3 months.;Timepoint(s) of evaluation of this end point: Every 9 weeks.	—

Measure

Time frame

Main Objective: To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression-free survival (PFS) rate at 3 months among patients without KRAS mutation as compared to maintenance treatment with bevacizumab alone.;Secondary Objective: To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumours. To evaluate the efficacy in terms of progression free and overall survival. To perform translational research for prognostic and treatment predictive markers.;Primary end point(s): To evaluate maintenance treatment with bevacizumab+erlotinib versus bevacizumab alone in patients with KRAS WT tumors following first line chemo- and anti-angiogenetic therapy by comparing progression-free survival rate at 3 months.;Timepoint(s) of evaluation of this end point: Every 9 weeks.

—

Secondary

Measure	Time frame
Secondary end point(s): To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression-free survival (PFS) rate at 3 months among patients without KRAS mutation as compared to maintenance treatment with bevacizumab alone.;Timepoint(s) of evaluation of this end point: Every 9 weeks.	—

Countries

Sweden

Contacts

Public ContactJan Sundberg

Skåne University Hospital

jan.sundberg@skane.se+46 4617 70 34

Outcome results

None listed

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