XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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

Official Title
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XELOX III. Capecitabine (Xeloda) in Combination With Oxaliplatin (Eloxatin) as First-line Treatment of Patients With Advanced or Metastatic Colorectal Cancer. A Randomized Phase II Study

Conditions
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C04.588.274.476.411.307

Intervention / Treatment
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* Drug: Oxaliplatin (Eloxatin)
* Drug: Capecitabine (Xeloda)


Participation Criteria
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Eligibility Criteria
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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: Prior treatment with Eloxatin or Xeloda Peripheral neuropathy Evidence of CNS metastasis Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months) Past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer Administration of any other experimental drug under investigation within 2 weeks before randomisation Pregnant or breast feeding women Fertile patients must use adequate contraceptives

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Standard XELOX | Drug: Oxaliplatin (Eloxatin)<br> <br> Drug: Capecitabine (Xeloda)<br> <br> |
| Active Comparator: B<br>Chronomodulated XELOX | Drug: Oxaliplatin (Eloxatin)<br> <br> Drug: Capecitabine (Xeloda)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal neoplasm, Capecitabine (Xeloda), Oxaliplatin (Eloxatin), Advanced disease, Metastatic disease, First-line treatment, Phase II study