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