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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209625
First Posted: September 21, 2005
Last Update Posted: September 21, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
September 13, 2005
September 21, 2005
September 21, 2005
April 2000
Not Provided
objective tumor response
Same as current
No Changes Posted
Response duration, time to progression, median survival time, and safety
Same as current
Not Provided
Not Provided
 
Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer
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
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
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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: irinotecan
  • Drug: leucovorin
  • Drug: fluorouracil
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
November 2004
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00209625
HGCSG0001
Not Provided
Not Provided
Not Provided
Not Provided
Hokkaido Gastrointestinal Cancer Study Group
Not Provided
Study Chair: Masahiro Asaka, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
Hokkaido Gastrointestinal Cancer Study Group
April 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP