Trial | NCT00209625  Report issue

Title

Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer
Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer：Hokkaido Gastrointestinal Cancer Study Group:HGCSG0001

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    23
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
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.
Study Started
Apr 30
2000
Study Completion
Nov 30
2004
Last Update
Sep 21
2005
Estimate

Drug irinotecan

Drug leucovorin

Drug fluorouracil

Criteria 

Inclusion Criteria:

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 Criteria:

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.
No Results Posted