Breast CancerPhase 1NCT00085020
GW572016 and Trastuzumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2/Neu
A Phase 1 study testing trastuzumab and lapatinib ditosylate in people with Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- trastuzumab and lapatinib ditosylate
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Feb 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin.
- More than 4 weeks since prior radiotherapy
- More than 4 weeks since prior major surgery
- Recovered from all prior therapy
- More than 28 days since prior participation in another investigational study
- More than 28 days since prior investigational drugs
Who cannot join
- 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
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- 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
- concurrent administration of any of the following medications or substances:
- Antibiotics
- Clarithromycin
- Erythromycin
- Troleandomycin
- Ciprofloxacin
- Rifampin
- Norfloxacin
- Rifabutin
- HIV antivirals
- Delaviridine
- Indinavir
- Nelfinavir
- Ritonavir
- Saquinavir
- Efavirenz
- Nevirapine
- Amprenavir
- Lopinavir
- Anticonvulsants
- Phenytoin
- Carbamazepine
- Phenobarbital
- Antidepressants
- Fluoxetine
- Nefazodone
- Fluvoxamine
- Antifungals
- Itraconazole
- Ketoconazole
- Fluconazole
- Voriconazole
- Antacids (within 1 hour before and after study drug administration)
- Cimetidine
- Amiodarone
- Diltiazem
- Pioglitazone
- Hypericum perforatum (St. John's wort)
- Grapefruit or grapefruit juice
- Rifabutin
- Diethyldithiocarbamate
- Gestodene
- Mifepristone
- Modafinil
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Trastuzumab [Herceptin†]
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.
Read the detailed description
OBJECTIVES:
Primary
- Determine the optimally tolerated regimen of GW572016 when administered with trastuzumab (Herceptin^®) in patients with metastatic breast cancer that overexpresses HER2/neu.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine the pharmacokinetic parameters of this regimen in these patients.
- Determine the clinical response in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter, dose-escalation study of GW572016.
Patients receive oral GW572016 once daily on days 1-28 and trastuzumab (Herceptin^®) IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of GW572016 until the optimally tolerated regimen (OTR) is determined. The OTR is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the OTR is determined, 10-18 additional patients are entered and treated at the OTR.
Patients are followed at 28 days.
PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, lapatinib ditosylate
- Keywords
- stage IV breast cancer, male breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
lapatinib ditosylateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startMar 2004
- Primary completionDec 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Mark D. Pegram, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085020
- Sponsor's protocol ID
- CDR0000367118
- Other IDs
- UCLA-0305039, GSK-EGF10023
- Status last verified
- Aug 2012
- First submitted
- 10 Jun 2004
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Storniolo AM, Burris HA III, Overmoyer B, et al.: A phase I, open-label study of the safety, tolerability and pharmacokinetics of lapatinib (GW572016) in combination with trastuzumab. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-1040, 2005.
Burris III HA, Storniolo AM, Overmoyer EA, et al.: A phase I, open-label study of the safety, tolerability and pharmacokinetics of lapatinib (GW572016) in combination with trastuzumab. [Abstract] Breast Cancer Res Treat 88 (1): A-3043, 2004.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Trastuzumab [Herceptin†]
- ClinicalTrials.gov ID
- NCT00085020
- Acronym / sponsor ID
- CDR0000367118
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, male breast cancer, recurrent breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 11 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Determine the optimally tolerated regimen of GW572016 when administered with trastuzumab (Herceptin^®) in patients with metastatic breast cancer that overexpresses HER2/neu.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine the pharmacokinetic parameters of this regimen in these patients.
- Determine the clinical response in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter, dose-escalation study of GW572016.
Patients receive oral GW572016 once daily on days 1-28 and trastuzumab (Herceptin^®) IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of GW572016 until the optimally tolerated regimen (OTR) is determined. The OTR is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the OTR is determined, 10-18 additional patients are entered and treated at the OTR.
Patients are followed at 28 days.
PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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:
Key exclusion criteria (69 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumab | Biological | – |
| lapatinib ditosylate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Results publicationStorniolo AM, Burris HA III, Overmoyer B, et al.: A phase I, open-label study of the safety, tolerability and pharmacokinetics of lapatinib (GW572016) in combination with trastuzumab. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-1040, 2005.
- Results publicationBurris III HA, Storniolo AM, Overmoyer EA, et al.: A phase I, open-label study of the safety, tolerability and pharmacokinetics of lapatinib (GW572016) in combination with trastuzumab. [Abstract] Breast Cancer Res Treat 88 (1): A-3043, 2004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D. Pegram, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing trastuzumab and lapatinib ditosylate in people with Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 69 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00085020, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.