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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jungsil Ro, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00532714
First received: September 19, 2007
Last updated: December 27, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Breast Cancer Metastatic
Drug: Irinotecan plus capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan Plus Capecitabine in Patients With Antracycline and Taxane Pretreated Metastatic Breast Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the toxicity profiles of capecitabine and irinotecan combination To determine time to progression and overall survival [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: August 2006
Study Completion Date: December 2011
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532714

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Jungsil Ro, Chief, Center for Clinical Trials, National Cancer Center, Korea, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00532714     History of Changes
Other Study ID Numbers: NCCCTS-06-201
Study First Received: September 19, 2007
Last Updated: December 27, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Fluorouracil
Irinotecan
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014