GW572016 and Trastuzumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2/Neu

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

RATIONALE: GW572016 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving GW572016 with trastuzumab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of GW572016 when given together with trastuzumab in treating patients with metastatic breast cancer that overexpresses HER2/neu.

Key facts

Study ID

NCT00085020

Run by

Jonsson Comprehensive Cancer Center

People needed

13

Starts

2004-03-01

Expected to finish

2005-02-01

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed breast cancer
• Metastatic disease
• Measurable or evaluable disease
• HER2/neu overexpression (2+ or 3+) confirmed by immunohistochemistry and/or HER2 gene amplification by fluorescence in situ hybridization
• Brain metastases treated by surgery and/or radiotherapy allowed provided the following criteria are met:
• Neurologic status stable 2 weeks after discontinuing dexamethasone
• No concurrent anticonvulsants that induce metabolism (e.g., phenytoin, carbamazepine, or phenobarbital)
• 18 and over
• Male or female
• Karnofsky 70-100%
• Life expectancy, At least 12 weeks
• Hematopoietic
• Absolute granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if patient has liver metastases)
• Bilirubin < 1.5 mg/dL
• Creatinine clearance > 30 mL/min
• Cardiovascular
• LVEF > 50%
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 4 weeks after study participation
• Adequate venous access
• Able to swallow and retain oral medication
• Prior adjuvant/neoadjuvant chemotherapy allowed

You may not qualify if…

• extensive tumor, pleural effusions, or parenchymal masses) resulting in dyspnea at rest
• uncontrolled brain metastases or leptomeningeal disease
• prior myocardial infarction
• pre-existing cardiac dysfunction (e.g., congestive heart failure)
• clinically significant cardiac disease
• angina pectoris
• symptomatic intrinsic pulmonary disease (e.g., asthma or chronic obstructive pulmonary disease) resulting in dyspnea at rest
• pregnant or nursing
• active infection
• known hypersensitivity to Chinese Hamster Ovary cell proteins or any component of this product
• known immediate or delayed hypersensitivity reaction or idiosyncrasy to products of similar chemical composition as study drug
• known contraindications to trastuzumab (Herceptin\^®)
• malabsorption syndrome
• disease significantly affecting gastrointestinal function
• psychiatric disorder that would preclude study compliance
• other serious illness or condition
• concurrent biologic therapy
• prior cumulative dose of doxorubicin > 400 mg/m\^2 (including liposomal doxorubicin)
• concurrent hormonal therapy*
• concurrent glucocorticoids
• concurrent radiotherapy
• prior major resection of the stomach or small bowel that could affect absorption of GW572016
• concurrent cytotoxic therapy
• other concurrent anticancer therapy
• other concurrent investigational drugs during and for 28 days after study treatment

Where it is running

• Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.