NCT01552967UnknownPhase 2
A Phase II Trial Evaluating a Modified Regimen of Oxaliplatin and Capecitabine in First-Line Treatment of Metastatic Colorectal Adenocarcinoma
Sixth Affiliated Hospital, Sun Yat-sen University1 site in 1 country30 target enrollmentStarted: March 1, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Overall response rate according to RECIST 1.1
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Overall response rate according to RECIST 1.1
Time Frame: One year
Secondary Outcomes
- Time to progression(One year)
- overall survival(One Year)
- Safety data of this regimen(One Year)
Investigators
Jian Xiao
Principal Investigator
Sixth Affiliated Hospital, Sun Yat-sen University
Study Sites (1)
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