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

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hokkaido Gastrointestinal Cancer Study Group
• Treatments: Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

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.