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

Odense University Hospital

Status and phase

Completed

Phase 3

Phase 2

Conditions

C04.588.274.476.411.307

Treatments

Drug: Capecitabine (Xeloda)

Drug: Oxaliplatin (Eloxatin)

Study type

Interventional

Funder types

Other

Identifiers

NCT00212615

KFE 03.17

XELOX III

Details and patient eligibility

About

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

Enrollment

116 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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