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| ID | Type | Description | Link |
|---|---|---|---|
| UAB 0718 | Other Identifier | UAB ComprehensiveCancerCenter ClinicalTrialsReviewCommittee |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| OSI Pharmaceuticals | INDUSTRY |
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The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. This study will also determine what effects, good and/or bad, this drug has on the participants.
An investigator-initiated Phase II clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tarceva | Other | All patients will be prescribed erlotinib 150mg daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | 150 mg per day by mouth for 12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment | Number of participants who had the most frequently observed undesirable effects after exposure to study drug | 12 - 24 months |
| Percentage of Participants With Disease Free Status at 12 Months and 24 Months | Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment) | 12 - 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Demonstrating Survival at 12 Months and 24 Months. | Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy | 12 - 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eben Rosenthal, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tarceva | All patients will be prescribed Tarceva 150mg daily Erlotinib: 150 mg per day by mouth for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tarceva | All patients will be prescribed Tarceva 150mg daily Erlotinib: 150 mg per day by mouth for 12 months |
| 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 |
| 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 | Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment | Number of participants who had the most frequently observed undesirable effects after exposure to study drug | Posted | Number | participants | 12 - 24 months |
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|
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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 | Tarceva | All patients will be prescribed Tarceva 150mg daily Erlotinib: 150 mg per day by mouth for 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia leading to respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pt hospitalized for respiratory failure and pneumonia felt releated to disease recurrence |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acniform rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eben Rosenthal,MD | University of Alabama at Birmingham | 2059349713 | erosenthal@uabmc.edu |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| discontinued due to noncompliance |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| ECOG performance status | ECOG PS 0 Fully active,able to carry on all predisease performance without restriction
| Number | participants |
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| Tumor Stage at Study Start - Primary Tumor Stage (T) | Classification of Malignant Tumors based on the American Joint Committee on Cancer (AJCC) staging criteria. T indicates tumor size, extent, or penetration (depth) of the tumor. T1 is the smallest/least advanced,while T4 is the largest/most advanced. | Number | participants |
|
| Tumor Stage at Study Start - Regional Metastasis (N) | Classification of Malignant Tumors based on the American Joint Committee on Cancer (AJCC) staging criteria. N indicates the number of lymph nodes with cancer or the location of the cancer-involved lymph nodes. N0 = no regional lymph node metastasis N1 = a single ipsilateral lymph node <3 cm in greatest dimension N2 = a single ipsilateral lymph nodes 3-6 cm in size OR multiple ipsilateral, bilateral, or contralateral lymph nodes <6 cm in greatest dimension N3 = a lymph node >6 cm in greatest dimension | Number | participants |
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| Extent of recurrence | Number | participants |
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| Tumor subsite | location of primary tumor | Number | participants |
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| Procedure details | Number of participants who received coincident placement of tracheostomy or PEG tube during salvage surgery prior to enrollment | Number | participants |
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| Flap reconstruction | Number of participants who received flap reconstruction during salvage surgery prior to enrollment | Number | participants |
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| Neck dissection | Number of participants who received a neck dissection (either unilateral or bilateral) during salvage surgery prior to enrollment | Number | participants |
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| Histological tumor grade | Number | participants |
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| Histological features | Number | participants |
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| Primary | Percentage of Participants With Disease Free Status at 12 Months and 24 Months | Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment) | Posted | Number | percentage of participants | 12 - 24 months |
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|
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| Secondary | Percentage of Participants Demonstrating Survival at 12 Months and 24 Months. | Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy | Posted | Number | percentage of participants | 12 - 24 months |
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| 9 |
| 31 |
| 31 |
| 31 |
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| bleeding from throat | Surgical and medical procedures | Non-systematic Assessment | Pt hospitalized for throat bleeding felt related to disease progress |
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| stridor | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pt hospitalized for stridor and trach debulking, felt unrelated to study drug |
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| Bell's Palsy | Nervous system disorders | Non-systematic Assessment | Pt hospitalized and diagnosed with Bell's Palsy |
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| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pt hospitalized for pneumonia |
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| cardiac stents placed | Cardiac disorders | Non-systematic Assessment | Pt had cardiac stents placed; event deemed unrelated to protocol therapy |
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| H pylori infection | Infections and infestations | Non-systematic Assessment | Pt hospitalized for nausea and vomiting felt related to inadequate PEG and H pylori infection |
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| myocardial infarction | Cardiac disorders | Non-systematic Assessment | Pt hospitalized for MI felt possibly related to study drug |
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| ARDS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pt hospitalized for septic shock and ARDS related to pneumonia; unrelated to study drug |
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| fatigue | General disorders | Non-systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| anemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| weight loss | Investigations | Non-systematic Assessment |
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| decreased platelet count | Metabolism and nutrition disorders | Non-systematic Assessment |
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| hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| hypercalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| headache | Nervous system disorders | Non-systematic Assessment |
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| constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| hirsutism | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
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| depression | Psychiatric disorders | Non-systematic Assessment |
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| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| reflux | Gastrointestinal disorders | Non-systematic Assessment |
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| hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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