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First-line Therapy of Stage IV Colorectal Cancer

Primary Purpose

Stage IV Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Oxaliplatin, Capecitabine, Bevacizumab, Imatinib
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Colorectal Cancer focused on measuring AIO, colorectal cancer, 0205, Capecitabine, Oxaliplatin, Bevacizumab, Imatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Clinic for Haematology and Oncology
  • Städische Kliniken Esslingen
  • Klinikum St. Georg gGmbH
  • Johannes-Gutenberg-Universität Mainz
  • Klinikum Mannheim
  • Prosper-Hospital
  • Leopoldina Krankenhaus
  • Universitätsklinik Ulm

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

XELOX, Bevacizumab, Imatinib

Arm Description

Outcomes

Primary Outcome Measures

Dose limiting toxicity.

Secondary Outcome Measures

Assessment of overall response rate and progression free survival.

Full Information

First Posted
November 3, 2008
Last Updated
January 4, 2013
Sponsor
University of Cologne
Collaborators
Roche Pharma AG, Novartis, Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00784446
Brief Title
First-line Therapy of Stage IV Colorectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
Collaborators
Roche Pharma AG, Novartis, Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The monoclonal anti-VEGF antibody bevacizumab has been approved for the treatment of stage IV colorectal cancer. The tyrosine kinase inhibitor imatinib mesylate has been shown to efficiently target PDGF-signalling. Blocking PDGFR-signalling leads to disruption of pericytes from the endothelium and reverses the maturation status thereby enhancing the sensitivity to anti-VEGF therapy.This background forms a rationale for a combined therapeutic PDGF and VEGF inhibition. Since bevacizumab shows best activity when used in combination with chemotherapy, capecitabine and oxaliplatin are included in this protocol. Patients with stage IV colorectal cancer and no prior chemotherapy can enter the study. Patients receive oral imatinib once a day on days 1-21. Oral Capecitabine is given on days 1-14 bid, Oxaliplatin and Bevacizumab are given on day 1. Courses are repeated every 22 days in the absence of disease progression or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Colorectal Cancer
Keywords
AIO, colorectal cancer, 0205, Capecitabine, Oxaliplatin, Bevacizumab, Imatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XELOX, Bevacizumab, Imatinib
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, Capecitabine, Bevacizumab, Imatinib
Other Intervention Name(s)
Xeloda, Avastin, Imatinib, Eloxatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dose limiting toxicity.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Assessment of overall response rate and progression free survival.
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Hacker, PD Dr.
Organizational Affiliation
University Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Clinic for Haematology and Oncology
City
Cologne
State/Province
NRW
ZIP/Postal Code
50937
Country
Germany
Facility Name
Städische Kliniken Esslingen
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Klinikum St. Georg gGmbH
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
Johannes-Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Prosper-Hospital
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Facility Name
Leopoldina Krankenhaus
City
Schweinfurt
ZIP/Postal Code
97422
Country
Germany
Facility Name
Universitätsklinik Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

First-line Therapy of Stage IV Colorectal Cancer

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