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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 1/Phase 2
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

objective tumor response

Principal Investigator

Masahiro Asaka, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hokkaido Gastrointestinal Cancer Study Group

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

HGCSG0001

NCT ID:

NCT00209625

Start Date:

April 2000

Completion Date:

November 2004

Related Keywords:

  • Colorectal Cancer
  • Irinotecan, leucovorin, fluorouracil, PhaseI/II, colorectal cancer,
  • Colorectal Neoplasms
  • Gastrointestinal Neoplasms

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