Phase II Study of Irinotecan/Capecitabine in Patients With Antracycline/Taxane Pretreated MBC
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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 |
- 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 ]
- 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:
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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 |
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| Korea, Republic of | |
| National Cancer Center | |
| 809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769 | |
| 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 Neoplasms Neoplasms, Second Primary Neoplasms by Site Breast Diseases Skin Diseases Irinotecan Capecitabine Fluorouracil Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013