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

NCT00209625 | Completed Phase 1

• 1 other identifier: HGCSG0001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• objective tumor response

Secondary Outcomes (1)

• Response duration, time to progression, median survival time, and safety

Interventions

irinotecan DRUG

leucovorin DRUG

fluorouracil DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hokkaido Gastrointestinal Cancer Study Group: lead

Study Sites (1)

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8638, Japan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Masahiro Asaka, MD, PhD

  Hokkaido Gastrointestinal Cancer Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2000
• Study Completion: November 1, 2004
• Last Updated: September 21, 2005

Record last verified: 2000-04

Locations

JP (1)