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| ID | Type | Description | Link |
|---|---|---|---|
| E6501 | Other Identifier | ECOG |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Giving interferon alfa and isotretinoin together with paclitaxel may reduce resistance to the drug and allow the tumor cells to be killed.
PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin together with paclitaxel works in treating patients with recurrent small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive interferon alfa subcutaneously and oral isotretinoin on days 1 and 2 and paclitaxel IV over 1 hour on day 2 of weeks 1-6. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 37-83 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFN-alpha, 13-CRA, paclitaxel | Experimental | Interferon alpha: 6 million U/m2 on days 1 and 2 of each week for 6 weeks of an 8-week cycle 13-cis-retinoic acid: 1 mg/kg on days 1 and 2 of each week for 6 weeks of an 8-week cycle Paclitaxel: 75 mg/m2 on day 2 of each week for 6 weeks of an 8-week cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interferon alpha | Biological | Interferon alpha given subcutaneously, 6 million units per square meter of body surface area on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Response by RECIST Criteria (v 1.0) | Number of eligible, treated participants in each response category by RECIST criteria | Assessed every 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Time from registration to death. | Assessed every 3 months for 1 year then every 6 months |
| Progression-free Survival | Time from registration to documented disease progression (RECIST criteria) or death. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Aisner, MD | Rutgers Cancer Institute of New Jersey | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia | 30033 | United States | ||
| Rush-Copley Cancer Care Center |
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Participants were recruited from ECOG member institutions between February 24, 2004 and August 22, 2007. The first patient was accrued on May 26, 2004.
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| ID | Title | Description |
|---|---|---|
| FG000 | IFN Alpha, 13-Cis-RA, Paclitaxel | Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 13-cis-retinoic acid | Drug | 13-cis-retinoic acid given at 1 mg/kg of body weight by mouth on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity. |
|
|
| paclitaxel | Drug | paclitaxel administered intravenously with premedication at 75 mg/m2 of body surface area on day 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity. |
|
|
| Assessed every 6 weeks |
| Aurora |
| Illinois |
| 60507 |
| United States |
| Hinsdale Hematology Oncology Associates | Hinsdale | Illinois | 60521 | United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| Swedish-American Regional Cancer Center | Rockford | Illinois | 61104-2315 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Howard Community Hospital | Kokomo | Indiana | 46904 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Saint Joseph Regional Medical Center | South Bend | Indiana | 46617 | United States |
| Mercy Capitol Hospital | Des Moines | Iowa | 50307 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa | 52501 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | 55805-1983 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Miller - Dwan Medical Center | Duluth | Minnesota | 55805 | United States |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | United States |
| Meeker County Memorial Hospital | Litchfield | Minnesota | 55355 | United States |
| HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | United States |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | United States |
| HealthEast Cancer Care at St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | United States |
| HealthEast Cancer Care at Woodwinds Health Campus | Woodbury | Minnesota | 55125 | United States |
| Cancer Resource Center - Lincoln | Lincoln | Nebraska | 68510 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington | New Jersey | 08822 | United States |
| CCOP - Northern New Jersey | Hackensack | New Jersey | 07601 | United States |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | The Bronx | New York | 10466 | United States |
| Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| Grant Medical Center Cancer Care | Columbus | Ohio | 43215 | United States |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | United States |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| St. Rita's Medical Center | Lima | Ohio | 45801 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Mercy Medical Center | Springfield | Ohio | 45504 | United States |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | United States |
| Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | 43081 | United States |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Cancer Center of Paoli Memorial Hospital | Paoli | Pennsylvania | 19301-1792 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston | West Virginia | 25304 | United States |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | 26506 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Eligible and Treated |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | IFN 13CRA Paclitaxel | Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Response by RECIST Criteria (v 1.0) | Number of eligible, treated participants in each response category by RECIST criteria | Eligible, treated patients | Posted | Number | participants | Assessed every 6 weeks |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Survival | Time from registration to death. | Eligible, treated patients | Posted | Median | 95% Confidence Interval | months | Assessed every 3 months for 1 year then every 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Time from registration to documented disease progression (RECIST criteria) or death. | Eligible, treated patients | Posted | Median | 95% Confidence Interval | months | Assessed every 6 weeks |
|
|
Assessed weekly during treatment
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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 | IFN Alpha, 13-CRA, Paclitaxel | Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity | 21 | 34 | 33 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Transfusion-Red Blood Cells | Blood and lymphatic system disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Fatigue | General disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Alkaline Phosphatase Increased | Investigations | NCI CTCAE Version 2 | Systematic Assessment |
| |
| AST Increased | Investigations | NCI CTCAE Version 2 | Systematic Assessment |
| |
| ALT Increased | Investigations | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Febrile Neutropenia | Investigations | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Infection with Grade 3 or 4 Neutropenia | Infections and infestations | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Infection without Neutropenia | Infections and infestations | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Amylase Increased | Investigations | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Lipase Increased | Investigations | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| "Neuropathy, Motor" | Nervous system disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Edema | General disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Fever | General disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Rigors/Chills | General disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Weight Loss | Investigations | NCI CTCAE Version 2 | Systematic Assessment |
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| Constitutional | General disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Prothrombin Time Increased | Investigations | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Rash/Desquamation | Skin and subcutaneous tissue disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Mouth Dryness | Gastrointestinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Taste Disturbance | Nervous system disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Bilirubin Increased | Investigations | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Confusion | Psychiatric disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Dizziness/Lightheadedness | Nervous system disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Depression | Psychiatric disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Neuropathy, Sensory | Nervous system disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Pain, Abdominal | Gastrointestinal disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Pain, Bone | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Headache | Nervous system disorders | NCI CTCAE Version 2 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Pain, Other | General disorders | NCI CTCAE Version 2 | Systematic Assessment |
| |
| Creatinine Increased | Investigations | NCI CTCAE Version 2 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG Statistical Office | 617-632-3012 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| D007438 | Introns |
| D015474 | Isotretinoin |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D004224 | Diterpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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| Title | Measurements |
|---|---|
|
| Unevaluable |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|