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

NCT ID: NCT00693719

Last Updated: 2015-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2013-05-31

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 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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Etoposide and Irinotecan hydrochloride

Irinotecan 100 mg/m2 IV days 1 and 15. Etoposide 50 mg PO x14 days followed by 2 weeks off.

Group Type: EXPERIMENTAL

Etoposide

Intervention Type: DRUG

50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle

Irinotecan hydrochloride

Intervention Type: DRUG

Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle

Interventions

Etoposide

50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle

Intervention Type: DRUG

Irinotecan hydrochloride

Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle

Intervention Type: DRUG

Other Intervention Names

Vepesid; Irinotecan hydrochloride trihydrate

Eligibility Criteria

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

• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert B. Livingston, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Countries

United States

References

Segar JM, Reed D, Stopeck A, Livingston RB, Chalasani P. A Phase II Study of Irinotecan and Etoposide as Treatment for Refractory Metastatic Breast Cancer. Oncologist. 2019 Dec;24(12):1512-e1267. doi: 10.1634/theoncologist.2019-0516. Epub 2019 Aug 5.

Reference Type: DERIVED

PMID: 31383812 (View on PubMed)

Other Identifiers

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UARIZ-BIO07046

Identifier Type: OTHER

Identifier Source: secondary_id

UARIZ-143

Identifier Type: OTHER

Identifier Source: secondary_id

PFIZER-GA59608L

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UARIZ-P18089

Identifier Type: OTHER

Identifier Source: secondary_id

07-0327-04

Identifier Type: -

Identifier Source: org_study_id