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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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
C04.588.274.476.411.307

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Per Pfeiffer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, Odense University Hospital

Authority:

Denmark: Central Scientific Ethical Committee

Study ID:

XELOX III

NCT ID:

NCT00212615

Start Date:

February 2004

Completion Date:

October 2008

Related Keywords:

  • C04.588.274.476.411.307
  • Colorectal neoplasm
  • Capecitabine (Xeloda)
  • Oxaliplatin (Eloxatin)
  • Advanced disease
  • Metastatic disease
  • First-line treatment
  • Phase II study
  • Colorectal Neoplasms

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