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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

NCT ID: NCT00209625

Last Updated: 2005-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2004-11-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Colorectal Cancer

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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irinotecan

Intervention Type DRUG

leucovorin

Intervention Type DRUG

fluorouracil

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hokkaido Gastrointestinal Cancer Study Group

OTHER

Sponsor Role lead

Principal Investigators

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Masahiro Asaka, MD, PhD

Role: STUDY_CHAIR

Hokkaido Gastrointestinal Cancer Study Group

Locations

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Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status

Countries

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Japan

Other Identifiers

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HGCSG0001

Identifier Type: -

Identifier Source: org_study_id