Clinical trial NCT00212615: XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: C04.588.274.476.411.307
Keywords: Colorectal neoplasm
Capecitabine (Xeloda)
Oxaliplatin (Eloxatin)
Advanced disease
Metastatic disease
First-line treatment
Phase II study
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
Secondary outcomes:
measure: Physical examination: before treatment (each 3 weeks)
measure: Performance status: before treatment (each 3 weeks)
measure: Haematology: before treatment (each 3 weeks)
measure: Tumor biology: after 1st treatment, every 9th weeks herafter
measure: Biochemistry: after every 3rd treatment (each 9th weeks)
measure: Tumor assesment: after every 3rd treatment (each 9th weeks)
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Department of Oncology, Esbjerg Hospital
city: Herlev
country: Denmark
facility: Department of Oncology, Herlev University Hospital
city: Herning
country: Denmark
facility: Department of Oncology, Herning Hospital
city: Hillerød
country: Denmark
facility: Department of Oncology, Hillerød Hospital
city: Næstved
country: Denmark
facility: Department of Oncology, Næstved Hospital
city: Roskilde
country: Denmark
facility: Department of Oncology, Roskilde Hospital
city: Stockholm
country: Sweden
facility: Department of Oncology, Radiumhemmet
city: Uppsala
country: Sweden
facility: Department of Oncology, Uppsala University Hospital
Study officials:
affiliation: Department of Oncology, Odense University Hospital
name: Per Pfeiffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1080/02841860310015894.
citation: Boisen MK, Johansen JS, Dehlendorff C, Larsen JS, Osterlind K, Hansen J, Nielsen SE, Pfeiffer P, Tarpgaard LS, Hollander NH, Keldsen N, Hansen TF, Jensen BB, Jensen BV. Primary tumor location and bevacizumab effectiveness in patients with metastatic colorectal cancer. Ann Oncol. 2013 Oct;24(10):2554-2559. doi: 10.1093/annonc/mdt253. Epub 2013 Jul 17.