Trastuzumab and Irinotecan in Treating Patients With HER2/Neu Positive Metastatic Breast Cancer

NCT00303992 | Completed Phase 2 DMC

• 3 other identifiers: 037517UCSF-037517UCSF-H6961-24269-02A
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with irinotecan may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving trastuzumab together with irinotecan works in treating patients with HER2/neu positive metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (2)

• Overall objective response rate (partial and complete responses)

  up to 20 months post treatment

• Stable disease rate

  up to 20 months post treatment

Secondary Outcomes (4)

• Toxicity

  up to 20 months post treatment

• Duration of response

  up to 20 months post treatment

• Time to disease progression

  up to 20 months post treatment

• Development of brain metastases or progression of known metastases on this treatment

  up to 20 months post treatment

Study Arms (1)

Trastuzumab and Irinotecan

EXPERIMENTAL

Biological: trastuzumab; Drug: irinotecan hydrochloride

Interventions

trastuzumab BIOLOGICAL

Trastuzumab and Irinotecan

irinotecan hydrochloride DRUG

Trastuzumab and Irinotecan

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: * Histologically or cytologically confirmed metastatic breast carcinoma * Received 1-3 prior chemotherapy regimens for metastatic disease * Documented progressive disease * Repeated courses of the same chemotherapy agent alone or in combination are considered a single regimen * Prior trastuzumab (Herceptin®) alone or with chemotherapy allowed * Other biologic agents are not considered a chemotherapy regimen * Measurable disease * Patients with bone-only disease who are evaluable by tumor markers (e.g., CA15-3, CEA, or CA27.29) are eligible * Patients must have prior evidence of correlation of disease activity with changes in tumor marker level * Confirmation of HER2/neu status by a positive test for gene amplification by fluorescence in situ hybridization or 3+ by immunohistochemistry * Brain metastases allowed if the following criteria are met: * Brain metastases were previously treated and are currently stable as documented by head CT scan with contrast or MRI within 4 weeks of study entry * Patients with existing brain metastases should have stability documented by prior imaging ≥ 8 weeks before the baseline scan * Hormone-receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status ≤ 2 * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Life expectancy ≥ 12 weeks * No history of congestive heart failure * Documented ejection fraction ≥ 45% by MUGA scan or echocardiogram within 1 month of study entry * Total bilirubin \< 3 times upper limit of normal (ULN) * AST \< 3 times ULN (5 times ULN if due to liver involvement) * Creatinine \< 1.5 times ULN * No history of serious adverse events related to trastuzumab * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No severe, concurrent illness that would prevent compliance with study protocol * No chronic severe diarrheal illness * No history of Gilbert's disease or known deficiency in glucuronidation * No recent or current history of alcoholism or acute viral hepatitis PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No chemotherapy or hormonal therapy within the past 2 weeks * Prior or concurrent bisphosphonates allowed * No prior irinotecan (other camptothecins allowed) * No concurrent radiotherapy * No ongoing treatment with any other investigational agent

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115-1710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Irinotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Hope S. Rugo, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Judy M. Cheng, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

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: March 15, 2006
• First Posted: March 17, 2006
• Study Start: May 1, 2004
• Primary Completion: November 16, 2006
• Study Completion: January 1, 2013
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

US (1)