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

Phase 2

Completed

• Conditions: C04.588.274.476.411.307
• Interventions: Drug: Oxaliplatin (Eloxatin); Drug: Capecitabine (Xeloda)

• Registration Number: NCT00212615
• Lead Sponsor: Odense University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A	Capecitabine (Xeloda)	Standard XELOX
B	Oxaliplatin (Eloxatin)	Chronomodulated XELOX
B	Capecitabine (Xeloda)	Chronomodulated XELOX
A	Oxaliplatin (Eloxatin)	Standard XELOX

Primary Outcome Measures

Name	Time	Method
Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)

Secondary Outcome Measures

Name	Time	Method
Physical examination: before treatment (each 3 weeks)
Haematology: before treatment (each 3 weeks)
Tumor biology: after 1st treatment, every 9th weeks herafter
Performance status: before treatment (each 3 weeks)
Biochemistry: after every 3rd treatment (each 9th weeks)
Tumor assesment: after every 3rd treatment (each 9th weeks)

Trial Locations

Locations (8)

Department of Oncology, Hillerød Hospital; 🇩🇰 Hillerød, Denmark

Department of Oncology, Roskilde Hospital; 🇩🇰 Roskilde, Denmark

Department of Oncology, Radiumhemmet; 🇸🇪 Stockholm, Sweden

Department of Oncology, Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Department of Oncology, Esbjerg Hospital; 🇩🇰 Esbjerg, Denmark

Department of Oncology, Herlev University Hospital; 🇩🇰 Herlev, Denmark

Department of Oncology, Herning Hospital; 🇩🇰 Herning, Denmark

Department of Oncology, Næstved Hospital; 🇩🇰 Næstved, Denmark