Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer

University of Arizona

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Irinotecan hydrochloride

Drug: Etoposide

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00693719

P30CA016672 (U.S. NIH Grant/Contract)

UARIZ-BIO07046 (Other Identifier)

07-0327-04

PFIZER-GA59608L (Other Grant/Funding Number)

UARIZ-143 (Other Identifier)

UARIZ-P18089 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

Under 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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