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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000069295 | |||
| GENENTECH-OSI2365s | |||
| NCI-G02-2057 |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.
OBJECTIVES:
OUTLINE: This is a dose-escalation study of erlotinib. (Phase I closed to accrual as of 01/2004).
Patients receive oral erlotinib once daily beginning on day 2 and trastuzumab (Herceptin) IV over 30-90 minutes (1-4 hours after erlotinib) once weekly beginning on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for the phase I portion (closed to accrual as of 01/2004) and 27-81 patients will be accrued for the phase II portion of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | please see intervention description |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Biological | Day 1 4mg/kg IV 2 mg/kg IV weekly. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart. | Complete Response: The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission. Partial Response: A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission. | 5 years |
| Recommended Dose for Phase II | treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Objective Response | 5 years | |
| Incidence of Adverse Events | 5 years | |
| Serum Concentration of Herceptin at Specified Time-points. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Britten, MD | Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19299235 | Result | Britten CD, Finn RS, Bosserman LD, Wong SG, Press MF, Malik M, Lum BL, Slamon DJ. A phase I/II trial of trastuzumab plus erlotinib in metastatic HER2-positive breast cancer: a dual ErbB targeted approach. Clin Breast Cancer. 2009 Feb;9(1):16-22. doi: 10.3816/CBC.2009.n.003. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Phase 1 | trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly. erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| erlotinib hydrochloride | Drug | 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol. |
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| 4 months |
| FG001 |
| Treatment Phase 2 |
trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly. erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol. |
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| NOT COMPLETED |
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enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Phase 1 | trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly. erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol. |
| BG001 | Treatment Phase 2 | trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly. erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart. | Complete Response: The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission. Partial Response: A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission. | 12 patients with measurable disease and no prior trastuzumab in the metastatic setting considered evaluable at the recommended phase II dose level. 2 from phase 1 and 10 from phase 2 Excluded : 14 from Phase I: no measureable disease or previous trastuzumab. Phase II: Withdrawn due to disease complications | Posted | Number | participants | 5 years |
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| Secondary | Duration of Objective Response | Subjects that achieved objective response (4). All were from phase II. | Posted | Number | participants | 5 years |
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| Secondary | Incidence of Adverse Events | subjects evaluated for Serious Adverse Events (SAEs) | Posted | Number | participants affected by SAEs | 5 years |
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| Secondary | Serum Concentration of Herceptin at Specified Time-points. | Posted | Mean | 95% Confidence Interval | mcg/mL | 4 months |
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| Primary | Recommended Dose for Phase II | patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol. | Posted | Number | participants receiving each dose | treatment period |
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|
9.4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Phase 1 Plus Phase 2 | trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly. erlotinib hydrochloride: 50mg daily, 100 mg daily and 150 mg daily. | 16 | 27 | 22 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dehydration/pain management | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| hypertension with headache | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| pain/chest pressure/SOB | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment | back pain/neck pain/chest pressure-palpitations/shortness of breath |
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| LVEF less than the lower limit of normal | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| progressive brain mets | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| gastroenteritis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | gastroenteritis (per co-investigator, due to food poisoning) |
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| maculopapular rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| subendocardial myocardial infarction | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| anorexia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| dysgeusia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| elevated transaminases | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| epistaxis | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| headache | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| pruitus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Britten | Medical University of South Carolina | 843-792-4271 | britten@musc.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| greater than 6 months |
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| greater than 2 years |
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| Categories |
|---|
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| Day 7 trough |
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| Day 14 peak |
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| Day 14 trough |
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| Day 21 peak |
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| Day 21 trough |
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