First-line Therapy of Stage IV Colorectal Cancer
A Phase I/II Study of Capecitabine/Oxaliplatin (XELOX) in Combination With Bevacizumab and Imatinib as First-line Treatment of Patients With Stage IV Colorectal Cancer
2 other identifiers
interventional
51
1 country
8
Brief Summary
Assessment of safety and toxicity, definition of the dose limiting toxicity (DLT) of the combination therapy consisting of Capecitabine, Oxaliplatin, Bevacizumab and Imatinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2008
Longer than P75 for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
November 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 7, 2013
January 1, 2013
2.3 years
November 3, 2008
January 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose limiting toxicity.
6 weeks
Secondary Outcomes (1)
Assessment of overall response rate and progression free survival.
6 month
Study Arms (1)
XELOX, Bevacizumab, Imatinib
NO INTERVENTIONInterventions
Dose level I: Bevacizumab day 1: 7,5 mg/kg body weight Oxaliplatin day 1: 100 mg/m2 Capecitabine days 1-14 bid: 800 mg/m2 Imatinib days 1-21: 300 mg Repeat on day 22. Dose level II: Bevacizumab day 1: 7,5 mg/kg body weight Oxaliplatin day 1: 130 mg/m2 Capecitabine days 1-14 bid: 1000 mg/m2 Imatinib days 1-21: 300 mg Repeat on day 22.
Eligibility Criteria
You may qualify if:
- Histologically proven inoperable colorectal cancer
- Adult patients \>= 18 years of age
- ECOG \<2
You may not qualify if:
- Other malignancies with the exception of basal cell carcinoma or successfully treated carcinoma in situ of the cervix uteri.
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colognelead
- Roche Pharma AGcollaborator
- Novartiscollaborator
- Sanoficollaborator
Study Sites (8)
Medical Clinic for Haematology and Oncology
Cologne, North Rhine-Westphalia, 50937, Germany
Städische Kliniken Esslingen
Esslingen am Neckar, 73730, Germany
Klinikum St. Georg gGmbH
Leipzig, 04129, Germany
Johannes-Gutenberg-Universität Mainz
Mainz, 55131, Germany
Klinikum Mannheim
Mannheim, 68167, Germany
Prosper-Hospital
Recklinghausen, 45659, Germany
Leopoldina Krankenhaus
Schweinfurt, 97422, Germany
Universitätsklinik Ulm
Ulm, 89081, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrich Hacker, PD Dr.
University Cologne
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr.
Study Record Dates
First Submitted
November 3, 2008
First Posted
November 4, 2008
Study Start
April 1, 2008
Primary Completion
August 1, 2010
Study Completion
December 1, 2012
Last Updated
January 7, 2013
Record last verified: 2013-01