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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068021 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy before, during, and after radiation therapy in treating patients who have limited-stage small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of thoracic radiotherapy (TRT).
Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses.
After 2 courses of topotecan and paclitaxel, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT.
At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation.
Cohorts of 3-6 patients receive escalating doses of TRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity (phase I closed to accrual as of 5/27/2004).
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 3-73 patients will be accrued for this study (phase I closed to accrual as of 5/27/2004).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topotecan + paclitaxel + filgrastim + TRT + radiation | Experimental | Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses. After 2 courses of treatment, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT. At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological |
| ||
| amifostine trihydrate |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 2 years | at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local progression-free survival at 2 years | at 2 years | |
| Overall survival | Up to 5 years | |
| Time to progression |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
Limited disease confined to one hemithorax, the ipsilateral supraclavicular fossa, and encompassable within tolerable thoracic radiotherapy field
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Scott Okuno, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic - Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17336213 | Result | Garces YI, Okuno SH, Schild SE, Mandrekar SJ, Bot BM, Martens JM, Wender DB, Soori GS, Moore DF Jr, Kozelsky TF, Jett JR. Phase I North Central Cancer Treatment Group Trial-N9923 of escalating doses of twice-daily thoracic radiation therapy with amifostine and with alternating chemotherapy in limited stage small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):995-1001. doi: 10.1016/j.ijrobp.2006.10.034. | |
| Result | Garces YI, Okuno SH, Schild SE, et al.: A phase I/II NCCTG trial of escalating doses of twice daily thoracic radiation therapy (TRT) in limited-stage small cell lung cancer (LSCLC). [Abstract] J Clin Oncol 23 (Suppl 16): A-7163, 661s, 2005. |
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| Drug |
|
| cisplatin | Drug |
|
| etoposide | Drug |
|
| paclitaxel | Drug |
|
| topotecan hydrochloride | Drug |
|
| radiation therapy | Radiation |
|
| Up to 5 years |
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60507 | 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 |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic | Galesburg | Illinois | 61401 | United States |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | United States |
| InterCommunity Cancer Center of Western Illinois | Galesburg | Illinois | 61401 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Hopedale Medical Complex | Hopedale | Illinois | 61747 | United States |
| Joliet Oncology Hematology Associates, Limited - West | Joliet | Illinois | 60435 | 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 |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61603 | 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 |
| 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 |
| Valley Cancer Center | Spring Valley | Illinois | 61362 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| McFarland Clinic, P.C. | Ames | Iowa | 50010 | United States |
| St. Luke's Hospital | Cedar Rapids | Iowa | 52402 | United States |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City | Iowa | 50401 | United States |
| Siouxland Regional Cancer Center | Sioux City | Iowa | 51101-1733 | United States |
| Siouxland Hematology-Oncology Associates | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, P.A. - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Kingman | Kingman | Kansas | 67068 | United States |
| Southwest Medical Center | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas, P.A. - Parsons | Parsons | Kansas | 67357 | United States |
| Pratt Cancer Center of Kansas | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas - Salina | Salina | Kansas | 67042 | United States |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health | Wichita | Kansas | 67203 | United States |
| Cancer Center of Kansas, P.A. | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, P.A. - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48100 | United States |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106-0995 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123 | United States |
| Hurley Medical Center | Flint | Michigan | 48502 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48532 | United States |
| Seton Cancer Institute - Saginaw | Saginaw | Michigan | 48601 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48903 | United States |
| MeritCare Clinic - Bemidji | Bemidji | Minnesota | 56601 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Bryan LGH Medical Center West | Lincoln | Nebraska | 68502 | United States |
| Cancer Resource Center - Lincoln | Lincoln | Nebraska | 68510 | United States |
| St. Elizabeth Regional Medical Center | Lincoln | Nebraska | 68510 | United States |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | United States |
| Cancer Care Center at Medcenter One Hospital | Bismarck | North Dakota | 58501 | United States |
| Mid Dakota Clinic, P.C. | Bismarck | North Dakota | 58501 | United States |
| St. Alexius Medical Center | Bismarck | North Dakota | 58501 | United States |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | United States |
| MeritCare Medical Group | Fargo | North Dakota | 58122 | United States |
| Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota | 58201 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| Geisinger Medical Group | State College | Pennsylvania | 16801 | United States |
| Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota | 57104 | United States |
| Avera McKennan Hospital and University Health Center | Sioux Falls | South Dakota | 57105 | United States |
| Medical X-Ray Center | Sioux Falls | South Dakota | 57105 | United States |
| Franciscan Skemp Healthcare | La Crosse | Wisconsin | 54601 | United States |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D008175 | Lung Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D004999 | Amifostine |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D063086 | Organothiophosphates |
| D010755 | Organophosphates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D009946 | Organothiophosphorus Compounds |
| D013457 | Sulfur Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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