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

Phase 2
18 Years
75 Years
Open (Enrolling)
Colorectal Adenocarcinoma

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Trial Information

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

Primary endpoint: Overall Response Rate

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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Overall response rate according to RECIST 1.1

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Jian Xiao

Investigator Role:

Principal Investigator

Investigator Affiliation:

the Sixth Affiliated Hospital of Sun Yat-sen University


China: Ethics Committee

Study ID:




Start Date:

March 2012

Completion Date:

February 2014

Related Keywords:

  • Colorectal Adenocarcinoma
  • Colorectal cancer
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms