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

NCT ID: NCT01552967

Last Updated: 2012-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-02-28

Brief 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.

Detailed Description

Primary endpoint: Overall Response Rate

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

Conditions

Colorectal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Capecitabine

Oxaliplatin 85mg/m2 D1 and capecitabine 1g/m2 BID D1-D10, repeat every two weeks.

Efficacy will be evaluated every three cycles.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jian Xiao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Xiao

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yue Cai, Master

Role: CONTACT

chilly8518@163.com

86-20-38250745

Facility Contacts

Yue Cai, Master

Role: primary

chilly8518@163.com

86-20-38250745

Other Identifiers

SAHMO-01

Identifier Type: -

Identifier Source: org_study_id