Efficacy and Safety Study of a Modified XELOX Regimen in First-Line Treatment of Metastatic Colorectal Adenocarcinoma

Colorectal Adenocarcinoma Clinical Trial

— mXELOX  

Official title:

A Phase II Trial Evaluating a Modified Regimen of Oxaliplatin and Capecitabine in First-Line Treatment of Metastatic Colorectal Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01552967
• Other study ID #: SAHMO-01
• Status: Recruiting
• Phase: Phase 2
• First received: March 5, 2012
• Last updated: March 27, 2012
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2012
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Yue Cai, Master
• Phone: 86-20-38250745
• Email: chilly8518[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is an open-label, phase II study to evaluate the efficacy and safety of a modified regimen of oxaliplatin and capecitabine on metastatic colorectal adenocarcinoma in the first-line therapy.

Description:

Primary endpoint: Overall Response Rate

Secondary endpoint: Time to progression, overall survival, safety data

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Signed written informed consent;

• Patients with histologically or cytologically confirmed stage IV colorectal adenocarcinoma whose ECOG performance status are 0-2;

• Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination;

• At least 3 weeks since last major surgery;

• At least 12 months since last adjuvant chemotherapy;

• At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected;

• Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields;

• Patients with reproductive potential must use effective BC;

• Required Screening Laboratory Criteria:

• Hemoglobin 90g/L

• WBC 3.5 x 109/L

• Neutrophils 1.5 x 109/L

• Platelets 100 x 109/L

• Creatinine 133 umol/L and creatinine clearance 60 mL/min

• A probable life expectancy of at least 6 months;

Exclusion Criteria:

• Brain metastases;

• Female of childbearing potential, pregnancy test is positive;

• Concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer;

• Active infection;

• Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk;

• Sexually active patients refusing to practice adequate contraception;

• Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator;

• History of grade 3 or 4 toxicity to fluoropyrimidines;

• Pre-existing neuropathy = NCI CTC grade 2.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinoma

Intervention

Drug:
• Capecitabine
Oxaliplatin 85mg/m2 D1 and capecitabine 1g/m2 BID D1-D10, repeat every two weeks. Efficacy will be evaluated every three cycles.

Locations

Country	Name	City	State
China	the Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate according to RECIST 1.1		One year	Yes
Secondary	Time to progression		One year	Yes
Secondary	overall survival		One Year	Yes
Secondary	Safety data of this regimen		One Year	Yes