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Safety and Efficacy Study of XELOX Vs. Oxaliplatin+5-FU CI as First Line Treatment in Metastatic Colorectal Cancer

Information source: Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: (capecitabine, oxaliplatin, 5-fluorouracil) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Official(s) and/or principal investigator(s):
Enrique Aranda, Study Chair, Affiliation: Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)
Eduardo Díaz-Rubio, Study Chair, Affiliation: Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)

Summary

The purpose of this study is to determine time to disease progression of combination therapy with capecitabine and oxaliplatin (XELOX) vs. oxaliplatin and 5-fluorouracil in continous infusion (5-FU CI) as first line treatment in advanced or metastatic colorectal cancer

Clinical Details

Official title: Phase III, Multicenter, Ramdomised, Open-Label, Study to Evaluate the Safety and Efficacy of Combination Therapy With XELOX Vs. Oxaliplatin and 5-FU CI as First Line Treatment in Advanced or Metastatic Colorectal Cancer

Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Determine time to disease progression

Secondary outcome: Determine safety of combination, objetive response rate, time to onset of response , duration of response, time to treatment failure, one year survival time, overall survival time

Detailed description: The purpose of this study is to determine time to disease progression of combination therapy with capecitabine and oxaliplatin (XELOX) vs. oxaliplatin and 5-fluorouracil in continous infusion (5-FU CI) as first line treatment in advanced or metastatic colorectal cancer

Eligibility

Minimum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

Written informed consent. Men and women > or = 18 years Karnofsky functional status >or=70% at the time of enrollment in study Histologically confirmed diagnosis of CRC Patients must not have received chemotherapy (exception: adjuvant treatment > 12 months following conclusion of treatment) Presence of at least one lesion detectable by two-dimensional measurement.. Life expectancy greater than 3 months.

Exclusion Criteria:

Pregnant or nursing woman Prior administration of systemic immunotherapy, chemotherapy (exception: 5-FU as adjuvant treatment > 12 months following conclusion of treatment) Evidence of allergic reaction to any of the treatment components Clinically relevant myocardial disease or history of myocardial infarction in the past 12 months Documented or suspected cerebral and/or leptomeningeal metastases. Prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or pre-invasive cervical carcinoma.

Neutrophil count < 1. 5 x 109/l , platelets < 100 X 109/l serum creatinine > 1. 5 x ULN. Total bilirubin count > 2 x ULN Alkaline Phosphatase > > 2. 5 x ULN (> 5 x ULN if there are hepatic metastases) Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) > 2. 5 x ULN (> 5 x ULN if there are hepatic metastases, > 10 x ULN if there are bone metastases) Creatinine clearance < 30 ml/min Surgery within 4 weeks prior to enrollment in the study. Any investigational drug during the 4 weeks prior to enrolment. Uncontrolled active infection Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent

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Locations and Contacts

Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD), Madrid 28046, Spain
Additional Information

Starting date: April 2002
Ending date: December 2005
Last updated: September 12, 2005

Page last updated: October 19, 2007

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