Status:
COMPLETED
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)
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to main...
Detailed Description
OBJECTIVES: Primary * Compare Progression-free survival during maintenance period ("Maintenance PFS")in patients with unresectable metastatic colorectal cancer. Secondary * Compare the duration of...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00265824
Start Date
May 1 2005
Last Update
December 11 2015
Active Locations (47)
Enter a location and click search to find clinical trials sorted by distance.
1
LKH Leoben
Leoben, Austria, 8700
2
LKH Steyr
Steyr, Austria, 4400
3
AKH Universitätsklinik für Innere Medizin I
Vienna, Austria, 1090
4
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600