Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan, leucovorin plus fluorouracil. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), median survival time (MST), incidence and severity of adverse event.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histological diagnosis of colorectral adenocarcinoma.
Measurable or assessable lesions.
Age: 18 ~ 75 years.
Performance Status (ECOG): 0 ~ 2.
No prior chemotherapy. Adjuvant chemotherapy is not defined as previous therapy.
No history of radiotherapy to the abdomen.
Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
Predicted survival for >3 months.
Able to give written informed consent.
Severe pleural effusion or ascites.
Metastasis to the central nervous system (CNS).
Active gastrointestinal bleeding.
Diarrhea (watery stools).
Uncontrolled ischemic heart disease.
Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
Active multiple cancer.
Severe mental disorder.
Pregnancy, possible pregnancy, or breast-feeding.
Judged to be ineligible for this protocol by the attending physician.