Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva. - Full Text View

Sponsors and Collaborators:	Lund University Hospital Hoffmann-La Roche
Information provided by:	Lund University Hospital
ClinicalTrials.gov Identifier:	NCT00598156

Purpose

Chemotherapy and bevacizumab given for 4 months. Patients who not have progressed will continue with maintenance treatment with either bevacizumab alone, or bevacizumab and erlotinib.

Condition	Intervention	Phase
Metastatic Colorectal Cancer	Drug: bevacizumab and erlotinib Drug: bevacizumab	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.

Further study details as provided by Lund University Hospital:

Primary Outcome Measures:

progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression	Drug: bevacizumab and erlotinib Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)
2: Experimental bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab every third week until progression	Drug: bevacizumab Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.8 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.11.Pregnant or lactating.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598156

Contacts

Contact: Anders Johnsson, MD PhD	+46 46 177520	anders.johnsson@onk.lu.se
Contact: Jan Sundberg, RN	+46 46 178548	jan.sundberg@skane.se

Locations

Sweden
Department of Oncology Lund University Hospital	Recruiting
Lund, Sweden, 22185
Contact: Jan Sundberg, RN +4646178548 jan.sundberg@skane.se

Sponsors and Collaborators

Lund University Hospital

Hoffmann-La Roche

Investigators

Principal Investigator:

Anders Johnsson, MD PhD

Lund University Hospital Sweden

More Information

Responsible Party:	Lund University Hospital Sweden ( Department of Oncology )
Study ID Numbers:	ML19033, EUDRACT 2006-002295-18
Study First Received:	January 9, 2008
Last Updated:	January 22, 2008
ClinicalTrials.gov Identifier:	NCT00598156
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Erlotinib
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Bevacizumab
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Growth Substances

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009