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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CALGB-30303 | |||
| CDR0000350089 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy.
PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
NOTE: *In both arms, darbepoetin alfa is administered SC on day 1 of each course for hemoglobin ≤ 11 g/dL.
In both arms, treatment repeats every 2 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy without BNP7787 | Experimental | Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC |
|
| Chemotherapy + BNP7787 | Experimental | Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| darbepoetin alfa | Biological | 200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response | during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs | |
| Survival | q 6 mon for 2 yrs after registration, then annually |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed* non-small cell lung cancer of 1 of the following subtypes:
Stage IIIB disease due to malignant pleural effusion OR stage IV disease
Measurable disease
At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
The following are considered nonmeasurable disease:
Brain metastases are allowed provided patient is neurologically stable and off steroids
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Antonius Miller, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Camino Hospital | Mountain View | California | 94040 | United States | ||
| Beebe Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18827613 | Result | Miller AA, Wang XF, Gu L, Hoffman P, Khatri J, Dunphy F, Edelman MJ, Bolger M, Vokes EE, Green MR; Cancer and Leukemia Group B (CALGB). Phase II randomized study of dose-dense docetaxel and cisplatin every 2 weeks with pegfilgrastim and darbepoetin alfa with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (CALGB 30303). J Thorac Oncol. 2008 Oct;3(10):1159-65. doi: 10.1097/JTO.0b013e318186fb0d. |
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| pegfilgrastim | Biological | 6 mg sub Q day 2 of each cycle |
|
| cisplatin | Drug | 75 mg/sq m IV over 1 hr Day 1 of each cycle |
|
| docetaxel | Drug | 75 mg/sq m IV over 1 hr Day 1 of each cycle |
|
| BNP7787 | Drug | 40 g IV over 30 min Day 1 of each cycle |
|
| Lewes |
| Delaware |
| 19958 |
| United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| St. Francis Hospital | Wilmington | Delaware | 19805 | United States |
| St. Joseph Medical Center | Bloomington | Illinois | 61701 | United States |
| Graham Hospital | Canton | Illinois | 61520 | United States |
| Memorial Hospital | Carthage | Illinois | 62321 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612-7243 | United States |
| Veterans Affairs Medical Center - Chicago Westside Hospital | Chicago | Illinois | 60612 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Louis A. Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic | Galesburg | Illinois | 61401 | United States |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Hopedale Medical Complex | Hopedale | Illinois | 61747 | United States |
| Kewanee Hospital | Kewanee | Illinois | 61443 | United States |
| McDonough District Hospital | Macomb | Illinois | 61455 | United States |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | United States |
| Community Hospital of Ottawa | Ottawa | Illinois | 61350 | United States |
| Oncology Hematology Associates of Central Illinois - Ottawa | Ottawa | Illinois | 61350 | United States |
| Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | 61554 | United States |
| Proctor Hospital | Peoria | Illinois | 61614 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615 | United States |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| OSF St. Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | United States |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | United States |
| St. Margaret's Hospital | Spring Valley | Illinois | 61362 | United States |
| Hematology Oncology Associates of the Quad Cities | Bettendorf | Iowa | 52722 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Veterans Affairs Medical Center - Baltimore | Baltimore | Maryland | 21201 | United States |
| Union Hospital Cancer Center at Union Hospital | Elkton MD | Maryland | 21921 | United States |
| Missouri Baptist Cancer Center | St Louis | Missouri | 63131 | United States |
| Arch Medical Services, Incorporated at Center for Cancer Care Research | St Louis | Missouri | 63141 | United States |
| Cancer Resource Center - Lincoln | Lincoln | Nebraska | 68510 | United States |
| Methodist Cancer Center at Methodist Hospital - Omaha | Omaha | Nebraska | 68114 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131-2197 | 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 |
| New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett | New Hampshire | 03106 | United States |
| Lakes Region General Hospital | Laconia | New Hampshire | 03246 | United States |
| Elliot Regional Cancer Center | Manchester | New Hampshire | 03103 | United States |
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls | New York | 12801 | United States |
| CCOP - Hematology-Oncology Associates of Central New York | Syracuse | New York | 13057 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Community General Hospital of Greater Syracuse | Syracuse | New York | 13215 | United States |
| Faxton Regional Cancer Center | Utica | New York | 13502 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Lenoir Memorial Cancer Center | Kinston | North Carolina | 28501 | United States |
| Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington | North Carolina | 28401 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| Cancer Care Associates - Mercy Campus | Oklahoma City | Oklahoma | 73120 | United States |
| McLeod Regional Medical Center | Florence | South Carolina | 29501 | United States |
| Veterans Affairs Medical Center - Dallas | Dallas | Texas | 75216 | United States |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | United States |
| Zale Lipshy University Hospital | Dallas | Texas | 75235 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| St. Mary's Regional Cancer Center at St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D008175 | Lung Neoplasms |
| D009503 | Neutropenia |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D064419 | Chemically-Induced Disorders |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| C455861 | pegfilgrastim |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| C027032 | 2,2'-dithiodiethanesulfonic acid |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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