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

NCT01552967 | Unknown Phase 2 DMC

• 1 other identifier: SAHMO-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Adenocarcinoma

Keywords

Colorectal cancer; Adenocarcinoma; XELOX

Outcome Measures

Primary Outcomes (1)

• Overall response rate according to RECIST 1.1

  One year

Secondary Outcomes (3)

• Time to progression

  One year

• overall survival

  One Year

• Safety data of this regimen

  One Year

Interventions

Capecitabine DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Adenocarcinoma

Interventions

Capecitabine

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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jian Xiao

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Cai, Master

CONTACT

86-20-38250745; chilly8518@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 13, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 28, 2012

Record last verified: 2012-03

Locations

CN (1)