Status:
COMPLETED
Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
Up to 120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving...
Detailed Description
OBJECTIVES: Primary * To determine the response rate, as assessed by RECIST criteria, in patients with recurrent locally advanced or metastatic breast cancer treated with irinotecan hydrochloride an...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of locally advanced or metastatic breast cancer
- Recurrent, refractory or progressive disease after receiving prior anthracycline, taxane, and capecitabine therapy
- Prior anthracycline and taxane therapy may have been as neoadjuvant, or adjuvant therapy if disease progression is documented within a year of completing that agent
- Received prior capecitabine therapy for metastatic or recurrent disease
- Measurable disease
- Bone metastases requires other disease present that can be measured
- No brain metastases, unless documented to be controlled post-completion of local therapy (surgery and/or radiation therapy) for at least 4 weeks
- No meningeal carcinomatosis
- No malignant effusion as the only site of disease recurrence
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Performance status of 0-2
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 40 mL/min
- Hemoglobin ≥ 10 g/dL
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin normal or hyperbilirubinemia \< grade 1 (unless due to Gilbert syndrome with elevated total but normal levels of conjugated bilirubin)
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other non-breast malignancy, except nonmelanoma skin cancer
- No other serious underlying medical condition, that in the opinion of the treating physician, would make study protocol unreasonably hazardous for the patient or would preclude the patient's ability to comply with the study protocol
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristic
- Recovered from all prior chemotherapy or radiotherapy to NCI CTC grade ≤ 1
- Unlimited documented prior chemotherapy regimens allowed
- No prior irinotecan hydrochloride or etoposide
- No Hypericum perforatum (St. John's wort) 14 days prior to, during, or 7 days after completion of study therapy
- At least 7 days since prior and no concurrent phenytoin, carbamazepine, phenobarbital, or any other enzyme-inducing anticonvulsant drug (EIACD)
- No concurrent aprepitant
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00693719
Start Date
August 1 2007
End Date
May 1 2013
Last Update
November 20 2015
Active Locations (1)
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1
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024