Clinical trial NCT00209625: Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Keywords: Irinotecan, leucovorin, fluorouracil, PhaseI/II, colorectal cancer,
Lead sponsor: Hokkaido Gastrointestinal Cancer Study Group
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: objective tumor response
Secondary outcomes:
measure: Response duration, time to progression, median survival time, and safety
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
Study officials:
affiliation: Hokkaido Gastrointestinal Cancer Study Group
name: Masahiro Asaka, MD, PhD
role: STUDY_CHAIR
References: