Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| S0330 | Other Identifier | SWOG | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with unresectable or metastatic malignant peripheral nerve sheath tumor.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients who achieve at least a confirmed partial response and become resectable undergo surgical resection (with or without radiotherapy) and then receive 2 additional courses of erlotinib. Patients with responding disease who do not become resectable continue erlotinib as above. Patients achieving a complete response (CR) receive 2 additional courses of erlotinib beyond the CR.
Patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (OSI-774) | Experimental | Drug: erlotinib hydrochloride Other Names: OSI-774 150 mg per day, daily until disease progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib hydrochloride | Drug | 150 mg per day, daily until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib. | Complete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions. | 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Only adverse events that are possibly, probably or definitely related to study drug are reported. | Up to 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug. | NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY | |
| Feasibility of Accruing These Patients in the Cooperative Group Setting |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant peripheral nerve sheath tumor
Measurable disease
No known current CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Ophthalmic
No known history of any of the following corneal diseases:
No other active disorders of the cornea
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen H. Albritton, MD | Dana-Farber Cancer Institute | Study Chair |
| R. Lor Randall, MD, FACS | University of Utah | Study Chair |
| Scott M. Schuetze, MD, PhD | University of Michigan Rogel Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Albritton KH, Rankin C, Coffin CM, et al.: Phase II study of erlotinib in metastatic or unresectable malignant peripheral nerve sheath tumors (MPNST). [Abstract] J Clin Oncol 24 (Suppl 18): A-9518, 524s, 2006. |
Not provided
Not provided
Four patients enrolled to study were found to be ineligible. One patient did not have measurable disease, one patient had radiotherapy 19 days prior to registration and two patients were found ineligible upon pathology review.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (OSI-774) | OSI-774 150 mg daily for 25 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY |
| University of California Davis Cancer Center |
| Davis |
| California |
| 95616 |
| United States |
| Contra Costa Regional Medical Center | Martinez | California | 94553-3156 | United States |
| St. Anthony Central Hospital | Denver | Colorado | 80204 | United States |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver | Colorado | 80217-3364 | United States |
| Montrose Memorial Hospital Cancer Center | Montrose | Colorado | 81401 | United States |
| St. Anthony North Hospital | Westminster | Colorado | 80030 | United States |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342 | United States |
| Northside Hospital Cancer Center | Atlanta | Georgia | 30342 | United States |
| Saint Joseph's Hospital of Atlanta | Atlanta | Georgia | 30342 | United States |
| WellStar Cobb Hospital | Austell | Georgia | 30106 | United States |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur | Georgia | 30033 | United States |
| Gwinnett Medical Center | Lawrenceville | Georgia | 30045 | United States |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | United States |
| Southern Regional Medical Center | Riverdale | Georgia | 30274 | United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | 62781-0001 | United States |
| St. Francis Hospital and Health Centers | Beech Grove | Indiana | 46107 | United States |
| McFarland Clinic, P.C. | Ames | Iowa | 50010 | United States |
| Baton Rouge General Regional Cancer Center | Baton Rouge | Louisiana | 70806 | United States |
| Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Medical Center of Louisiana - New Orleans | New Orleans | Louisiana | 70112 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | 49017 | United States |
| Mecosta County General Hospital | Big Rapids | Michigan | 49307 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health Cancer Care - Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Metropolitan Hospital | Grand Rapids | Michigan | 49506 | United States |
| Spectrum Health Hospital - Blodgett Campus | Grand Rapids | Michigan | 49506 | United States |
| Holland Community Hospital | Holland | Michigan | 49423 | United States |
| Hackley Hospital | Muskegon | Michigan | 49443 | United States |
| Northern Michigan Hospital | Petoskey | Michigan | 49770 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Deaconess Billings Clinic - Downtown | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare | Billings | Montana | 59101 | United States |
| Deaconess Billings Clinic Cancer Center | Billings | Montana | 59107 | United States |
| Bozeman Deaconess Hospital | Bozeman | Montana | 59715 | United States |
| St. James Community Hospital | Butte | Montana | 59701 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Eastern Montana Cancer Center | Miles City | Montana | 59301 | United States |
| Community Medical Center | Missoula | Montana | 59801 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59802 | United States |
| Methodist Cancer Center at Methodist Hospital - Omaha | Omaha | Nebraska | 68114 | United States |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Wilson Medical Center | Wilson | North Carolina | 27893 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Community Oncology Group - Independence | Independence | Ohio | 44131 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Middletown Regional Hospital | Middletown | Ohio | 45044 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373 | United States |
| Cleveland Clinic - Wooster | Wooster | Ohio | 44691 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | United States |
| Providence Milwaukie Hospital | Milwaukie | Oregon | 97222 | United States |
| Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center | Portland | Oregon | 97210 | United States |
| Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Institute of Oncology at Vilnius University | Portland | Oregon | 97227 | United States |
| Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| Auburn Regional Center for Cancer Care | Auburn | Washington | 98002 | United States |
| St. Joseph Hospital Community Cancer Center | Bellingham | Washington | 98225 | United States |
| Olympic Hematology and Oncology | Bremerton | Washington | 98310 | United States |
| Regional Cancer Center at Providence Hospital | Centralia | Washington | 98531 | United States |
| St. Francis Hospital | Federal Way | Washington | 98003 | United States |
| Skagit Valley Hospital Cancer Care Center | Mount Vernon | Washington | 98273 | United States |
| Providence St. Peter Hospital Regional Cancer Center | Olympia | Washington | 95806 | United States |
| Capital Medical Center | Olympia | Washington | 98507 | United States |
| Good Samaritan Cancer Center | Puyallup | Washington | 98372 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98104 | United States |
| Group Health Central Hospital | Seattle | Washington | 98104 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98114 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| North Puget Oncology at United General Hospital | Sedro-Woolley | Washington | 98284 | United States |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | United States |
| Allenmore Hospital | Tacoma | Washington | 98405 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405 | United States |
| St. Joseph Medical Center at Franciscan Health System | Tacoma | Washington | 98405 | United States |
| St. Clare Hospital | Tacoma | Washington | 98499 | United States |
| Southwest Washington Medical Center Cancer Center | Vancouver | Washington | 98668 | United States |
| Central Washington Hospital | Wenatchee | Washington | 98801 | United States |
| Wenatchee Valley Clinic | Wenatchee | Washington | 98801 | United States |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg | West Virginia | 26101 | United States |
| Welch Cancer Center | Sheridan | Wyoming | 82801 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (OSI-774) | OSI-774 150 mg daily for 25 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Prior multi-agent chemotherapy | Count of Participants | 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 | Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib. | Complete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions. | Posted | Count of Participants | Participants | 25 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Toxicity | Only adverse events that are possibly, probably or definitely related to study drug are reported. | All participants receiving at least some protocol treatment | Posted | Number | Participants | Up to 25 weeks |
|
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug. | NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY | Posted |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Feasibility of Accruing These Patients in the Cooperative Group Setting | NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY | Not Posted | Participants |
Up to 25 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (OSI-774) | OSI-774 150 mg daily for 25 weeks | 12 | 20 | 19 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Chest/thorax NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death - Disease progression NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Neuralgia/peripheral nerve | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular/Visual-Other | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI - Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI - Upper GI NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symp) - Oral cav | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death not associated with CTCAE term - Death NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: head and neck | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever in absence of neutropenia, ANC lt1.0x10e9/L | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Chest/thorax NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-Other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - Sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - UTI | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Chest wall | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Neck | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death - Disease progression NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leak, cerebrospinal fluid (CSF) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular/Visual-Other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Neuralgia/peripheral nerve | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hair loss/Alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage/Bleeding-Other | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | SWOG Statistical Center | 206-667-4623 | sarcoma@crab.org |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D018319 | Neurofibrosarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005354 | Fibrosarcoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Unknown or Not Reported |
|
| Denominators |
|---|
| Categories |
|---|
| Anorexia |
| |||||
| Diarrhea |
| |||||
| Dyspnea (shortness of breath) |
| |||||
| Fatigue (asthenia, lethargy, malaise) |
| |||||
| Hemoglobin |
| |||||
| Nausea |
| |||||
| Pain - Abdomen NOS |
| |||||
| Pruritus/itching |
| |||||
| Rash/desquamation |
| |||||
| Somnolence/depressed level of consciousness |
| |||||
| Vision-blurred vision |
|