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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202774
• Other study ID #: 03-TTD-01
• Status: Completed
• Phase: Phase 3
• Start date: April 2002
• Est. completion date: December 2005

Study information

• Verified date: April 2019
• Source: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: December 2005
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine time to disease progression
Secondary	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