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Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Neoplasms, Secondary, Drug Therapy, Combination

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Trial Information

Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With 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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximal response rate and toxicities

Outcome Time Frame:

During treatment

Principal Investigator

Kyung Hae Jung, M.D.

Investigator Role:

Principal Investigator


Korea: Food and Drug Administration

Study ID:




Start Date:

November 2001

Completion Date:

July 2007

Related Keywords:

  • Colorectal Neoplasms
  • Secondary
  • Drug Therapy, Combination
  • Colorectal neoplasms
  • Secondary
  • Drug therapy, combination
  • Irinotecan
  • Capecitabine
  • Neoplasms
  • Colorectal Neoplasms