Status:
COMPLETED
Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer
Lead Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
We performed a phase I/II study of CPT-11/5FU/l-LV in advanced colorectal cancer, to determine the optimal dose of CPT-11 and to estimate the safety and efficacy of this regimen
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Severe pleural effusion or ascites.
- Metastasis to the central nervous system (CNS).
- Active gastrointestinal bleeding.
- Active infection.
- 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.
- Flucytosine treatment
- Gilbert's syndrome.
- Judged to be ineligible for this protocol by the attending physician.
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00209625
Start Date
April 1 2000
End Date
November 1 2004
Last Update
September 21 2005
Active Locations (1)
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1
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8638