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| ID | Type | Description | Link |
|---|---|---|---|
| HRPP# 060769 |
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Study was terminated due to slow subject accrual
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The main purpose of this research study is to see if adding fulvestrant (Faslodex) to erlotinib (Tarceva) is effective in patients with stage IIIb/IV Non-Small Cell Lung Cancer.
Erlotinib is an oral drug which is able to block endothelial growth factor receptor (EGFR). EGFR stimulates cancer cell growth. Fulvestrant (faslodex) block estrogen hormone from gaining access to tumor and stimulating the tumor cells to grow. Both of these drugs are already approved by FDA but have not been studied in this combination.
We will study if the combination of these drugs will delay treatment failure. Lung cancer tumors in both males and females can be sensitive to estrogen. Only patients whose tumor expresses the estrogen will be eligible for the trial. Estrogen sensitivity will be tested on previously removed tumor specimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Single-arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant and Erlotinib | Drug | Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | 14 weeks after start of fulvestrant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Patients will be followed until death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyudmila Bazhenova, M.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores UCSD Cancer Center | La Jolla | California | 92093-0698 | United States |
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| Label | URL |
|---|---|
| Moores UCSD Cancer Center Homepage | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fulvestrand and Erlotinib | Single-arm study Fulvestrant and Erlotinib : Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fulvestrant and Erlotinib | Single-arm study Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Progression-free Survival | Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available. | Posted | 14 weeks after start of fulvestrant |
|
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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 | A: Fulvestrant and Erlotinib | Single-arm study Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acneiform Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lyudmila Bazhenova, MD | UC San Diego, Moores Cancer Center | 858 822 6189 | lbazhenova@ucsd.edu |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Overall Survival | Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available. | Posted | Patients will be followed until death |
|
|
| 0 |
| 7 |
| 7 |
| 7 |
| Dermatology - Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Pain - Arthralgia | Nervous system disorders | Systematic Assessment |
|
| Paronychia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Bronchorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash in Groin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Left Groin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Changes in Equilibrium | Ear and labyrinth disorders | Systematic Assessment |
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| Double Vision | Nervous system disorders | Systematic Assessment |
|
| Night Sweats | Immune system disorders | Systematic Assessment |
|
| Hot Flashes | Endocrine disorders | Systematic Assessment |
|
| Decreased Appetite | General disorders | Systematic Assessment |
|
| Weight Loss | General disorders | Systematic Assessment |
|
| Right Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lower Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Draining Sinuses | Infections and infestations | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Weakness | General disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Cardiac Murmur | Cardiac disorders | Systematic Assessment |
|
| ALT Elevated | Investigations | Systematic Assessment |
|
| AST Elevated | Investigations | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Nosebleed | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |