XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
Study Details
Study Description
Brief Summary
XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).
Bloodsamples will be collected and frozen and later examined for potential predictive factors
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: A Standard XELOX |
Drug: Oxaliplatin (Eloxatin)
Drug: Capecitabine (Xeloda)
|
Active Comparator: B Chronomodulated XELOX |
Drug: Oxaliplatin (Eloxatin)
Drug: Capecitabine (Xeloda)
|
Outcome Measures
Primary Outcome Measures
- Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event) []
Secondary Outcome Measures
- Physical examination: before treatment (each 3 weeks) []
- Performance status: before treatment (each 3 weeks) []
- Haematology: before treatment (each 3 weeks) []
- Tumor biology: after 1st treatment, every 9th weeks herafter []
- Biochemistry: after every 3rd treatment (each 9th weeks) []
- Tumor assesment: after every 3rd treatment (each 9th weeks) []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histological proven adenocarcinoma of the colon or rectum
-
Measurable or non-measurable disease
-
Performance status 0-2
-
Adequate renal and hepatic functions
-
Adjuvant chemotherapy must have ended 180 days before inclusion
-
Written informed consent prior to randomization
Exclusion Criteria:
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Prior treatment with Eloxatin or Xeloda
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Peripheral neuropathy
-
Evidence of CNS metastasis
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Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months)
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Past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer
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Administration of any other experimental drug under investigation within 2 weeks before randomisation
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Pregnant or breast feeding women
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Fertile patients must use adequate contraceptives
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Oncology, Esbjerg Hospital | Esbjerg | Denmark | 6700 | |
2 | Department of Oncology, Herlev University Hospital | Herlev | Denmark | 2730 | |
3 | Department of Oncology, Herning Hospital | Herning | Denmark | 7400 | |
4 | Department of Oncology, Hillerød Hospital | Hillerød | Denmark | 3400 | |
5 | Department of Oncology, Næstved Hospital | Næstved | Denmark | 4700 | |
6 | Department of Oncology, Roskilde Hospital | Roskilde | Denmark | 4000 | |
7 | Department of Oncology, Radiumhemmet | Stockholm | Sweden | 100 26 | |
8 | Department of Oncology, Uppsala University Hospital | Uppsala | Sweden | 751 85 |
Sponsors and Collaborators
- Odense University Hospital
Investigators
- Principal Investigator: Per Pfeiffer, MD, Department of Oncology, Odense University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- XELOX III
- KFE 03.17