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| ID | Type | Description | Link |
|---|---|---|---|
| 105642 |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.
All patients will receive weekly topotecan.
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topotecan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topotecan | Drug | Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall toxicity | 18 months | |
| time to progression | 18 months | |
| duration of response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R. Spigel, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Arkansas Clinic | Jonesboro | Arkansas | 72401 | United States | ||
| Florida Cancer Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21663862 | Derived | Spigel DR, Greco FA, Burris HA 3rd, Shipley DL, Clark BL, Whorf RC, Arrowsmith ER, Hainsworth JD. A phase II study of higher dose weekly topotecan in relapsed small-cell lung cancer. Clin Lung Cancer. 2011 May;12(3):187-91. doi: 10.1016/j.cllc.2011.03.016. Epub 2011 Apr 28. |
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| 18 months |
| overall survival | 18 months |
| Fort Myers |
| Florida |
| 33901 |
| United States |
| Watson Clinic Center for Cancer Care and Research | Lakeland | Florida | 33805 | United States |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Consultants in Blood Disorders and Cancer | Louisville | Kentucky | 40207 | United States |
| Hematology Oncology Life Center | Alexandria | Louisiana | 71301 | United States |
| Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | United States |
| Methodist Cancer Center | Omaha | Nebraska | 68114 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Chattanooga Oncology Hematology Associates | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37023 | United States |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D018288 | Carcinoma, Small Cell |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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