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Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

Primary Purpose

Colorectal Neoplasms, Secondary, Drug Therapy, Combination

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Irinotecan, Capecitabine
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Colorectal neoplasms, Secondary, Drug therapy, combination, Irinotecan, Capecitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed metastatic colorectal cancer
  • ECOG performance status 0-2
  • Mesurable lesions
  • No prior chemotherapyk or radiotherapy for metastatic disease. Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
  • Adjuvnat chemo or radiotherapy was completed at least 6 months prior to start study treatment
  • Adequate organ functions
  • Expected survival is longer then 6 months
  • Informed consent

Exclusion Criteria:

  • Prior systemic chemotherapy for metastatic disease
  • Prior treatment with oxaliplatin or irinotecan
  • CNS metastases
  • Uncontrolled or severe cardiovascular disease
  • Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
  • Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
  • Psychiatric disorder or uncontrolled seizure that would preclude compliance
  • Pregnant, nursing women or patients with reproductive potential without contraception
  • Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucytosine, phenytoin, or warfarin et al.
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery

Sites / Locations

  • National Cancer Center Korea

Outcomes

Primary Outcome Measures

Maximal response rate and toxicities

Secondary Outcome Measures

Progression-free survival and overall survival

Full Information

First Posted
July 23, 2007
Last Updated
July 23, 2007
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00506168
Brief Title
Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer
Official Title
Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Terminated
Why Stopped
The study drugs are not covered anymore by insurance.
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.
Detailed Description
This is a single center, single arm, open-label, phase II study to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer. Patients younger then 65 will be treated with irinotecan 100 mg/m2 on day 1 and 8 and capecitabine 1,000mg/m2 twice daily from day 1 to 14 every 3 weeks.For patiens equal to or older then 65, doses of irinotecan and capecitabine will be reduced to 60 mg/m2 and 750 mg/2, respectively. Response assessment will be performed every 3 cycles of chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Secondary, Drug Therapy, Combination
Keywords
Colorectal neoplasms, Secondary, Drug therapy, combination, Irinotecan, Capecitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Irinotecan, Capecitabine
Primary Outcome Measure Information:
Title
Maximal response rate and toxicities
Time Frame
During treatment
Secondary Outcome Measure Information:
Title
Progression-free survival and overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed metastatic colorectal cancer ECOG performance status 0-2 Mesurable lesions No prior chemotherapyk or radiotherapy for metastatic disease. Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration Adjuvnat chemo or radiotherapy was completed at least 6 months prior to start study treatment Adequate organ functions Expected survival is longer then 6 months Informed consent Exclusion Criteria: Prior systemic chemotherapy for metastatic disease Prior treatment with oxaliplatin or irinotecan CNS metastases Uncontrolled or severe cardiovascular disease Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix Psychiatric disorder or uncontrolled seizure that would preclude compliance Pregnant, nursing women or patients with reproductive potential without contraception Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucytosine, phenytoin, or warfarin et al. Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Hae Jung, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Korea
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

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