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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209625
• Other study ID #: HGCSG0001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: April 2000
• Est. completion date: November 2004

Study information

• Verified date: April 2000
• Source: Hokkaido Gastrointestinal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• irinotecan

• leucovorin

• fluorouracil

Locations

Country	Name	City	State
Japan	Hokkaido University Hospital	Sapporo	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
Hokkaido Gastrointestinal Cancer Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective tumor response
Secondary	Response duration, time to progression, median survival time, and safety