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

C04.588.274.476.411.307 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212615
• Other study ID #: XELOX III
• Secondary ID: KFE 03.17
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2004
• Est. completion date: October 2008

Study information

• Verified date: November 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• C04.588.274.476.411.307
• Colorectal Neoplasms

Intervention

Drug:
• Oxaliplatin (Eloxatin)

• Capecitabine (Xeloda)

Locations

Country	Name	City	State
Denmark	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, Hillerød Hospital	Hillerød
Denmark	Department of Oncology, Næstved Hospital	Næstved
Denmark	Department of Oncology, Roskilde Hospital	Roskilde
Sweden	Department of Oncology, Radiumhemmet	Stockholm
Sweden	Department of Oncology, Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Countries where clinical trial is conducted

Denmark,  Sweden, 

References & Publications (1)

Pfeiffer P, Hahn P, Jensen HA. Short-time infusion of oxaliplatin (Eloxatin) in combination with capecitabine (Xeloda) in patients with advanced colorectal cancer. Acta Oncol. 2003;42(8):832-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
Secondary	Physical examination: before treatment (each 3 weeks)
Secondary	Performance status: before treatment (each 3 weeks)
Secondary	Haematology: before treatment (each 3 weeks)
Secondary	Tumor biology: after 1st treatment, every 9th weeks herafter
Secondary	Biochemistry: after every 3rd treatment (each 9th weeks)
Secondary	Tumor assesment: after every 3rd treatment (each 9th weeks)