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

Sponsor

Hokkaido Gastrointestinal Cancer Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00209625

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: irinotecan Drug: leucovorin Drug: fluorouracil	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2000

Study Completion Date :

Nov 1, 2004

Outcome Measures

Primary Outcome Measures

objective tumor response []

Secondary Outcome Measures

Response duration, time to progression, median survival time, and safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8638

Sponsors and Collaborators

Hokkaido Gastrointestinal Cancer Study Group

Investigators

Study Chair: Masahiro Asaka, MD, PhD, Hokkaido Gastrointestinal Cancer Study Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00209625

Other Study ID Numbers:

HGCSG0001

First Posted:

Sep 21, 2005

Last Update Posted:

Sep 21, 2005

Last Verified:

Apr 1, 2000

Keywords provided by , ,

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

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2005