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Phase II Study of Irinotecan/Capecitabine in Patients With Antracycline/Taxane Pretreated MBC

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Completed
CT.gov ID
NCT00532714
Collaborator
(none)
36
Enrollment
1
Location
1
Arm
64
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer

Condition or Disease Intervention/Treatment Phase
  • Drug: Irinotecan plus capecitabine
 Phase 2

Detailed Description

This is a nonrandomized, open-label, phase II study of irinotecan plus capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes. Up to 44 qualified patients will be enrolled according to the exact single stage design.

Irinotecan 90 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period. Capecitabine is administered orally at a dose of 1,000 mg/m2 twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2 weeks of treatment followed by a 1-week rest period). For practical reasons, capecitabine doses are rounded to the nearest dose that could be administered with a combination of 500-mg and 150-mg tablets of drug. Capecitabine is given approximately 12 hours apart and taken orally with water within 30 minutes after ingestion of food (breakfast or dinner).

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Irinotecan Plus Capecitabine in Patients With Antracycline and Taxane Pretreated Metastatic Breast Cancer
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Irinotecan plus capecitabine

Irinotecan 80 mg/m2 (intravenously once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period) Capecitabine (orally at a dose of 1,000 mg/m2 twice daily 3-week cycles (2 weeks of treatment followed by a 1-week rest period))

Drug: Irinotecan plus capecitabine
Irinotecan 80 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period. Capecitabine is administered orally at a dose of 1,000 mg/m2 twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2 weeks of treatment followed by a 1-week rest period).
Other Names:
  • Crabcan
  • Xeloda

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer [2009]

    Secondary Outcome Measures

    1. To investigate the toxicity profiles of capecitabine and irinotecan combination To determine time to progression and overall survival [2009]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologic or cytologic diagnosis of breast cancer Stage IV or recurrent.

    • Previous chemotherapy with anthracyclines and taxane in adjuvant setting

    • Previous hormonal therapy in adjuvant and metastatic setting is allowed

    • Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.

    • No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study.

    • Performance status of 0, 1, 2 on the ECOG criteria.

    • Clinically measurable disease, defined as uni-dimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at least 1 cm, as defined by x-ray, CT scan, MRI, or physical examination.

    • Estimated life expectancy of at least 12 weeks.

    • Patient compliance that allow adequate follow-up.

    • Adequate hematologic (WBC count ³ 3,000/mm3, platelet count ³ 100,000/mm3), hepatic (bilirubin level £ 1.5 mg/dL), and renal (creatinine concentration £ 1.5 mg/dL) function.

    • Informed consent from patient or patient's relative.

    • Males or females at least 18 years of age.

    • If female: childbearing women should use non-hormonal contraceptive method

    Exclusion Criteria:

    • MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia.

    • Serious concomitant infection.

    • Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center 809 Madu1-dong, Ilsandong-gu, Goyang-si Gyeonggi-do Korea, Republic of 410-769

    Sponsors and Collaborators

    • National Cancer Center, Korea

    Investigators

    • Principal Investigator: Jungsil Ro, M.D., National Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jungsil Ro, Chief, Center for Clinical Trials, National Cancer Center, Korea, National Cancer Center, Korea
    ClinicalTrials.gov Identifier:
    NCT00532714
    Other Study ID Numbers:
    • NCCCTS-06-201
    First Posted:
    Sep 20, 2007
    Last Update Posted:
    Dec 30, 2011
    Last Verified:
    Dec 1, 2011
    Additional relevant MeSH terms:
    Breast Neoplasms
    Capecitabine
    Irinotecan

    Study Results

    No Results Posted as of Dec 30, 2011