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

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
erlotinib (Tarceva)
bevacizumab (Avastin)
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vejle Hospital, Department of Oncology
  • Esbjerg Hospital
  • Herning Hospital
  • Hillerod Hospital, Department of Oncology
  • Odense Hospital, Department of Oncology
  • Roskilde Hospital, Department of Oncology
  • Ryhov Hospital, Department of Oncology
  • Kalmar Hospital, Department of Oncology
  • Lund University Hospital, Department of Oncology
  • University Hospital MAS
  • Karolinska University Hospital, Department of Oncology
  • Sundsvall Hospital, Department of Oncology
  • University Hospital of Norrland, Department of Oncology
  • Akademiska Hospital, Department of Oncology
  • Vaxjo Hospital, Department of Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression

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

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

overall survival

Full Information

First Posted
January 9, 2008
Last Updated
April 19, 2013
Sponsor
Lund University Hospital
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00598156
Brief Title
Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva
Acronym
ACT
Official Title
Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression
Arm Title
2
Arm Type
Experimental
Arm Description
bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab every third week until progression
Intervention Type
Drug
Intervention Name(s)
erlotinib (Tarceva)
Intervention Description
Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)
Intervention Type
Drug
Intervention Name(s)
bevacizumab (Avastin)
Intervention Description
Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Johnsson, MD PhD
Organizational Affiliation
Lund University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vejle Hospital, Department of Oncology
City
Copenhagen
Country
Denmark
Facility Name
Esbjerg Hospital
City
Esbjerg
Country
Denmark
Facility Name
Herning Hospital
City
Herning
Country
Denmark
Facility Name
Hillerod Hospital, Department of Oncology
City
Hillerod
Country
Denmark
Facility Name
Odense Hospital, Department of Oncology
City
Odense
Country
Denmark
Facility Name
Roskilde Hospital, Department of Oncology
City
Roskilde
Country
Denmark
Facility Name
Ryhov Hospital, Department of Oncology
City
Jonkoping
Country
Sweden
Facility Name
Kalmar Hospital, Department of Oncology
City
Kalmar
Country
Sweden
Facility Name
Lund University Hospital, Department of Oncology
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
University Hospital MAS
City
Malmo
Country
Sweden
Facility Name
Karolinska University Hospital, Department of Oncology
City
Stockholm
Country
Sweden
Facility Name
Sundsvall Hospital, Department of Oncology
City
Sundsvall
Country
Sweden
Facility Name
University Hospital of Norrland, Department of Oncology
City
Umeå
Country
Sweden
Facility Name
Akademiska Hospital, Department of Oncology
City
Uppsala
Country
Sweden
Facility Name
Vaxjo Hospital, Department of Oncology
City
Vaxjo
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23922111
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.
Results Reference
derived
PubMed Identifier
23788755
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.
Results Reference
derived

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

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