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A PHASE II STUDY: IRINOTECAN AND ETOPOSIDE AS TREATMENT FOR REFRACTORY, METASTATIC BREAST CANCER


Phase 2
N/A
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

A PHASE II STUDY: IRINOTECAN AND ETOPOSIDE AS TREATMENT FOR REFRACTORY, METASTATIC BREAST CANCER


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response (complete and partial response) rate as assessed by RECIST criteria

Outcome Time Frame:

Every eight weeks

Safety Issue:

No

Principal Investigator

Robert B. Livingston, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

07-0327-04

NCT ID:

NCT00693719

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724