Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

This study has been terminated.
(The study drugs are not covered anymore by insurance.)
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00506168
First received: July 23, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted

July 23, 2007
July 23, 2007
November 2001
Not Provided
Maximal response rate and toxicities [ Time Frame: During treatment ]
Same as current
No Changes Posted
Progression-free survival and overall survival
Same as current
Not Provided
Not Provided
 
Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer
Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer

This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Neoplasms
  • Secondary
  • Drug Therapy, Combination
Drug: Irinotecan, Capecitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
37
July 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00506168
NCCCTS-01-024
No
Not Provided
National Cancer Center, Korea
Not Provided
Principal Investigator: Kyung Hae Jung, M.D.
National Cancer Center, Korea
July 2007

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