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Clinical Trial on Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III Among Chinese Population

Phase 2/Phase 3
18 Years
90 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Clinical Trial on Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III Among Chinese Population

This study will examine a new combination of drugs: 5-fluorouracil and capecitabine for the
treatment of Stage II and III colorectal cancer. 5-fluorouracil and capecitabine are
approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The
combination of drugs is experimental (not approved by the FDA as standard treatment), but is
a widely used treatment option and preliminary studies have shown that treatment with the
combination has a positive effect on metastatic colorectal cancer. In the present trial, we
will study the combination of these two drugs in patients with colorectal cancer among
Chinese population

Inclusion Criteria:

- Patient must have a histologically proven adenocarcinoma of colon or rectum with
metastases or local recurrence.

- Patients must have at least one measurable lesion according to the RECIST criteria.
Bone metastases, ascites and pleural effusion are not measurable.

- Minimum indicator lesion size as follows:

- Greater than or equal to 20 mm measured by conventional CT Greater than or equal
to 10 mm measured by spiral techniques

- Prior use of celecoxib for the treatment of nonmalignant disorders is allowed.

- Patients must have a performance status of 0,1, or 2 by the Southwest Oncology Group

- Patients must have a calculated creatinine clearance of greater than 50 ml/min.

- Patients must have an absolute neutrophil count of greater than or equal to 1500/ml,
platelet count greater than or equal to 100,000/ml, and total serum bilirubin equal
or less than the institution's upper limit or normal range.

- Patients must have recovered from any effects of surgery.

- Evaluable disease must be present outside radiation field. At least 3 weeks must have
elapsed after discontinuation of radiation therapy.

- Patients must provide a signed consent to participate in the study.

Exclusion Criteria:

- Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.

- Patients who have experienced asthma, urticaria, or allergic-type reactions after
taking aspirin or other non-steroidal anti-inflammatory drugs.

- Patients who have received prior chemotherapy for colorectal cancer (including
capecitabine or irinotecan) except for patients relapsing more than 6 months after
completion of adjuvant chemotherapy.

- History of other malignancy, except for cancers that have been treated with a
curative intent and patient is without evidence of active disease.

- Unresolved bacterial infection requiring treatment with antibiotics.

- Pregnant or lactating women may not participate in the study. Women/men of
reproductive age group may not participate unless they have agreed to use an
effective method of contraception.

- Patients who have allergy to any of the study drugs or sulfa drugs.

- Patients known to have HIV-1 virus infection because of the undetermined effect of
this chemotherapy regimen in patients with HIV-1 and the potential for serious
interaction with anti-HIV medications.

- Gilbert's disease.

- Lack of physical integrity of the upper gastrointestinal tract. Inability to swallow
tablets or those who have malabsorption syndrome.

- Other serious concurrent infection

- Clinically significant cardiac disease not well controlled with medication (e.g.
congestive heart failure, symptomatic coronary artery disease and cardiac
arrhythmias) or myocardial infarction within the last 12 months.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate of patients with metastatic colorectal cancer received the combination of drugs

Outcome Time Frame:

7 years

Safety Issue:


Principal Investigator

Qingchuan Zhao, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fourth Military Medical University


China: Ministry of Health

Study ID:




Start Date:

January 2004

Completion Date:

January 2012

Related Keywords:

  • Colorectal Cancer
  • efficiency
  • 5-fluorouracil
  • Capecitabine
  • colorectal cancer
  • Colorectal Neoplasms