Optimized Chemotherapy Followed by Maintenance With Bevacizumab With or Without Erlotinib in Treating Patients With Metastatic Colorectal Cancer That Cannot be Removed by Surgery (DREAM) (DREAM)
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, chemotherapy
Eligibility Criteria
MAIN ELIGIBILITY CRITERIA Histologically proven metastatic adenocarcinoma of colon or rectum Documented inoperable disease (i.e., not suitable for complete carcinological surgical resection) Measurable lesion as assessed by CT scan or MRI in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional CT scan or ≥ 10 mm with spiral CT scan No previous therapy for metastatic disease No history or evidence upon physical examination of CNS disease (e.g., non-irradiated CNS metastasis, seizure not controlled with standard medical therapy, or history of stroke) unless adequately treated No exclusive bone metastasis ECOG performance status 0-2 WBC ≥ 1,500/mm^3 Platelets ≥ 100,000/mm^3 Hemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Proteinuria < 2+ by dipstick OR ≤ 1 g of protein on 24-hr urine collection Bilirubin < 1.5 times ULN Alkaline phosphatase < 3 times ULN No peripheral sensory neuropathy Negative pregnancy test Fertile patients must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterilization) No peripheral neuropathy ≥ grade 1 No clinically significant (i.e. active) cardiovascular disease No evidence of bleeding diathesis or coagulopathy No serious, non-healing wound, ulcer, or bone fracture No significant ophthalmologic abnormality More than 28 days since prior major surgical procedure or open biopsy
Sites / Locations
- LKH Leoben
- LKH Steyr
- Klinikum Wels-Grieskirchen GmbH
- AKH Universitätsklinik für Innere Medizin I
- Ottawa Hospital Regional Cancer Centre
- Cité de la Santé de Laval
- CHUM Hôpital Notre-Dame
- Mc Gill University Hospital
- Hôpital Charles LeMoyne
- Hôpital Maisonneuve-Rosemont
- Centre Hospitalier
- Centre Hospitalier
- Centre Hospitalier
- Hôpital Avicenne
- Polyclinique Bordeaux Nord
- Centre Hospitalier
- Hôpital Pasteur
- Centre Hospitalier
- Hopital Drevon
- CHD les oudairies
- Clinique Victor Hugo
- Hopital Robert Boulin
- CHU Dupuytren
- Centre Hospitalier Saint Joseph Saint Luc
- Hôpital Privé Jean Mermoz
- Clinique de la sauvegarde
- hôpital Ambroise Paré
- Institu Paoli Calmette
- Centre Hospitalier
- Clinique Claude BERNARD
- Centre hospitalier Layné
- Centre Hospitalier Intercommunal Le Raincy - Montfermeil
- centre oncologie de Gentilly
- Centre Catherine de Sienne
- Institut Curie
- Groupe Hospitalier les Diaconnesses
- Hôpital Pitié Salpêtrière
- Hôpital Saint Joseph
- Institut Mutualiste Montsouris
- Hopital Saint Antoine
- Hopital Tenon
- centre Catalan oncologie
- Clinique Armoricaine
- Centre Hospitalier
- C.H. Senlis
- Hopital Foch
- Clinique Générale
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
bevacizumab alone
Bevacizumab + erlotinib