XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
Information source: Odense University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: C04.588.274.476.411.307
Intervention: Oxaliplatin (Eloxatin) (Drug); Capecitabine (Xeloda) (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Odense University Hospital Official(s) and/or principal investigator(s):
Per Pfeiffer, MD, Principal Investigator, Affiliation: Department of Oncology, Odense University Hospital
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
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
Secondary outcome: 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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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:
- 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
Locations and Contacts
Department of Oncology, Herning Hospital, Herning 7400, Denmark
Department of Oncology, Naestved Hospital, Naestved 4700, Denmark
Department of Oncology, Herlev University Hospital, Herlev 2730, Denmark
Department of Oncology, Hilleroed Hospital, Hilleroed 3400, Denmark
Department of Oncology, Roskilde Hospital, Roskilde 4000, Denmark
Department of Oncology, Esbjerg Hospital, Esbjerg 6700, Denmark
Department of Oncology, Uppsala University Hospital, Uppsala 751 85, Sweden
Department of Oncology, Radiumhemmet, Stockholm 100 26, Sweden
Additional Information
Related publications: 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.
Starting date: February 2004
Ending date: October 2008
Last updated: September 13, 2005
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