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

NCT00202774 | Completed Phase 3

• 1 other identifier: 03-TTD-01
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colorectal Cancer

Keywords

colorectal cancer, capecitabine, oxaliplatin, 5-fluorouracil

Outcome Measures

Primary Outcomes (1)

• Determine time to disease progression

Secondary Outcomes (1)

• 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

Interventions

(capecitabine, oxaliplatin, 5-fluorouracil) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD): lead

Study Sites (1)

Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Enrique Aranda

  Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)

  STUDY CHAIR

• Eduardo Díaz-Rubio

  Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2002
• Primary Completion: August 1, 2004
• Study Completion: December 1, 2005
• Last Updated: April 12, 2023

Record last verified: 2019-04

Locations

ES (1)