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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00209625

Enrollment

Registered

2005-09-21

Start date

2000-04-30

Completion date

2004-11-30

Last updated

2005-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Irinotecan, leucovorin, fluorouracil, PhaseI/II, colorectal cancer,

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 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.

Interventions

DRUGirinotecan

DRUGleucovorin

DRUGfluorouracil

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Histological diagnosis of colorectral adenocarcinoma. 2. Measurable or assessable lesions. 3. Age: 18 \ 75 years. 4. Performance Status (ECOG): 0 \ 2. 5. No prior chemotherapy. Adjuvant chemotherapy is not defined as previous therapy. 6. No history of radiotherapy to the abdomen. 7. 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). 8. Predicted survival for \>3 months. 9. Able to give written informed consent.

Exclusion criteria

1. Severe pleural effusion or ascites. 2. Metastasis to the central nervous system (CNS). 3. Active gastrointestinal bleeding. 4. Active infection. 5. Diarrhea (watery stools). 6. Uncontrolled ischemic heart disease. 7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). 8. Active multiple cancer. 9. Severe mental disorder. 10. Pregnancy, possible pregnancy, or breast-feeding. 11. Flucytosine treatment 12. Gilbert's syndrome. 13. Judged to be ineligible for this protocol by the attending physician.

Design outcomes

Primary

Measure	Time frame
objective tumor response	—

Secondary

Measure	Time frame
Response duration, time to progression, median survival time, and safety	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026