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

NCT00693719 | Completed Phase 2 Results DMC

• 6 other identifiers: 07-0327-04P30CA016672UARIZ-BIO07046UARIZ-143PFIZER-GA59608LUARIZ-P18089
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Median Time to Progression

  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months

Secondary Outcomes (1)

• Overall Survival

  Measured from the start of protocol therapy until the date of death from any cause or will be censored at the date the patient was last known to be alive, assesed up to 13 months

Study Arms (1)

Etoposide and Irinotecan hydrochloride

EXPERIMENTAL

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

Drug: Etoposide; Drug: Irinotecan hydrochloride

Interventions

Etoposide DRUG

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

Also known as: Vepesid

Etoposide and Irinotecan hydrochloride

Irinotecan hydrochloride DRUG

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

Also known as: Irinotecan hydrochloride trihydrate

Etoposide and Irinotecan hydrochloride

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

Related Publications (1)

• 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.

  PMID: 31383812 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Etoposide; Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Robert Livingston
• Organization: University of Arizona Cancer Center

rlivingston@azcc.arizona.edu

520/626-4175

Study Officials

• Robert B. Livingston, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 9, 2008
• Study Start: August 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: November 20, 2015
• Results First Posted: August 21, 2013

Record last verified: 2013-08

Locations

US (1)