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

NCT00532714 | Completed Phase 2

• 1 other identifier: NCCCTS-06-201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

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

  2009

Secondary Outcomes (1)

• To investigate the toxicity profiles of capecitabine and irinotecan combination To determine time to progression and overall survival

  2009

Study Arms (1)

Irinotecan plus capecitabine

NO INTERVENTION

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

Interventions

Irinotecan plus capecitabine DRUG

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).

Also known as: Crabcan, Xeloda

Irinotecan plus capecitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Interventions

Irinotecan; Capecitabine

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jungsil Ro, M.D.

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Center for Clinical Trials, National Cancer Center, Korea

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 20, 2007
• Study Start: August 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2011
• Last Updated: December 30, 2011

Record last verified: 2011-12

Locations

KR (1)