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Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

This study has been terminated.
(The study drugs are not covered anymore by insurance.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00506168
First Posted: July 25, 2007
Last Update Posted: July 25, 2007
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:
National Cancer Center, Korea
  Purpose
This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.

Condition Intervention Phase
Colorectal Neoplasms Secondary Drug Therapy, Combination Drug: Irinotecan, Capecitabine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Maximal response rate and toxicities [ Time Frame: During treatment ]

Secondary Outcome Measures:
  • Progression-free survival and overall survival

Enrollment: 37
Study Start Date: November 2001
Study Completion Date: July 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506168


Locations
Korea, Republic of
National Cancer Center Korea
Goyang, Gyeonggi, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Kyung Hae Jung, M.D.
  More Information

ClinicalTrials.gov Identifier: NCT00506168     History of Changes
Other Study ID Numbers: NCCCTS-01-024
First Submitted: July 23, 2007
First Posted: July 25, 2007
Last Update Posted: July 25, 2007
Last Verified: July 2007

Keywords provided by National Cancer Center, Korea:
Colorectal neoplasms
Secondary
Drug therapy, combination
Irinotecan
Capecitabine

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Irinotecan
Camptothecin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors