First-line Therapy of Stage IV Colorectal Cancer

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Assessment of safety and toxicity, definition of the dose limiting toxicity (DLT) of the combination therapy consisting of Capecitabine, Oxaliplatin, Bevacizumab and Imatinib.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne
• Collaborators: Novartis; Roche Pharma AG; Sanofi
• Treatments: Bevacizumab; Capecitabine; Imatinib Mesylate; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically proven inoperable colorectal cancer

• Adult patients >= 18 years of age

• ECOG <2

Exclusion Criteria:

• Preceding chemo- or immunotherapy with the exception of adjuvant or neoadjuvant treatment of non-metastatic disease ending ≥ 6 month prior to study inclusion. Progression within 6 month after the end of adjuvant therapy must be excluded.

• Other malignancies with the exception of basal cell carcinoma or successfully treated carcinoma in situ of the cervix uteri.

• No history of severe comorbidities, i. e. uncontrolled hypertension, GI-bleeding, congestive heart-failure NYHA class II-IV, symptomatic coronary heart disease, myocardial infarction within 1 year prior to study inclusion, serious cardiac arrhythmias requiring medication, Grade II or greater peripheral vascular disease and other severe uncontrolled co-morbidities

• No history of stroke or other CNS-diseases (tumors, seizure, transient ischemic attack etc.)

• ≥ Grade II peripheral artery vascular occlusive disease

• Preexisting neuropathy ≥ Grade 1

• Interstitial pneumonia or lung fibrosis

• Serious, nonhealing wound, ulcer, or bone fracture

• Preceding irradiation an indicator lesion except for documented progressive disease during irradiation and termination of irradiation ≥ 4 weeks from study inclusion

• Thromboembolic or bleeding events within the last 6 month

• Need for therapeutic anticoagulation (heparin, cumarin)

• Use of ASS > 325 mg/die or NSAR

• Proteinuria > 1+ (stix) as long as urine protein >1g/24h