Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer
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Purpose
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 more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with etoposide works in treating patients with recurrent, locally advanced, or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Etoposide Drug: Irinotecan hydrochloride |
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: | A PHASE II STUDY: IRINOTECAN AND ETOPOSIDE AS TREATMENT FOR REFRACTORY, METASTATIC BREAST CANCER |
- Clinical response (complete and partial response) rate as assessed by RECIST criteria [ Time Frame: Every eight weeks ] [ Designated as safety issue: No ]
- Response duration [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Every 8 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 31 |
| Study Start Date: | August 2007 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Etoposide/Irinotecan |
Drug: Etoposide
50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
Drug: Irinotecan hydrochloride
Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
|
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 and etoposide after prior exposure to anthracycline, taxane, and capecitabine therapy.
Secondary
- To determine the median time to progression in these patients.
- To determine the response duration and survival in these patients.
- To measure the type and rate of grade 3 or greater toxicity of this treatment regimen in these patients.
OUTLINE: Patients receive irinotecan hydrochloride IV on days 1 and 15 and oral etoposide on days 1-14. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
After completion of study therapy, patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724-5024 | |
| Principal Investigator: | Robert B. Livingston, MD | University of Arizona |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Arizona |
| ClinicalTrials.gov Identifier: | NCT00693719 History of Changes |
| Other Study ID Numbers: | 07-0327-04, P30CA016672, UARIZ-BIO07046, UARIZ-143, PFIZER-GA59608L, UARIZ-P18089 |
| Study First Received: | June 6, 2008 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arizona:
|
recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Etoposide Irinotecan Camptothecin Etoposide phosphate 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 |
ClinicalTrials.gov processed this record on May 22, 2013