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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000269348 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use 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 tumor cells.
PURPOSE: Phase I trial to study the effect on the body when combining irinotecan and cisplatin with radiation therapy in treating patients who have limited-stage small cell lung cancer that could not be completely removed during surgery.
OBJECTIVES:
OUTLINE: This is a non-randomized, dose-escalation study of irinotecan. Patients are assigned to 1 of 2 radiotherapy (RT) treatment groups.
Radiotherapy:
Concurrent chemotherapy: Patients receive irinotecan IV over 60-90 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 1 course for group I and 2 courses for group II.
Post RT chemotherapy: Patients receive irinotecan and cisplatin as above for 3 courses for group I and 2 courses, beginning after RT is complete, for group II.
Sequential cohorts of 6 patients per group receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year and then 6 months for 4 years.
PROJECTED ACCRUAL: A total of 12-36 patients (6-18 per group) will be accrued for this study within 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A: Level 1 | Experimental | Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID |
|
| Sequence B: Level 1 | Experimental | Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily |
|
| Sequence A: Level 2 | Experimental | Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID |
|
| Sequence B: Level 2 | Experimental | Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily |
|
| Sequence A: Level 3 | Experimental | Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity | From the start of treatment until 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of non-dose limiting toxicity | From start of treatment to the end of follow-up |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer by one of two methods:
Must have limited disease as defined by all of the following:
Stage I-IIIB
Confined to 1 hemithorax
No T4 tumor based on malignant pleural or pericardial effusion
No N3 disease based on contralateral hilar or contralateral supraclavicular involvement
Measurable or evaluable disease
No complete tumor resection
No pericardial effusion (regardless of cytology)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks
At least 14 days since prior Hypericum perforatum (St. John's wort)
No concurrent EIACDs
No concurrent amifostine during chemoradiotherapy
Concurrent gabapentin or other non-EIACDs allowed
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| Name | Affiliation | Role |
|---|---|---|
| Corey J. Langer, MD | Fox Chase Cancer Center | Study Chair |
| Maria Werner-Wasik, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Langer CJ, Swann S, Werner-Wasik M, et al.: Phase I study of irinotecan (Ir) and cisplatin (DDP) in combination with thoracic radiotherapy (RT), either twice daily (45 Gy) or once daily (70 Gy), in patients with limited (Ltd) small cell lung carcinoma (SCLC): early analysis of RTOG 0241. [Abstract] J Clin Oncol 24 (Suppl 18): A-7058, 378s, 2006. | ||
| Result | Langer C, Swann S, Werner-Wasik M, et al.: Phase I study of combination irinotecan and cisplatin and either twice daily thoracic radiation (45Gy) or once daily thoracic radiotherapy (70Gy) in patients with limited small cell lung carcinoma (SCLC): early toxicity analysis of RTOG 0241. [Abstract] Lung Cancer 49 (Suppl 2): A-P-777, S323, 2005. |
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| Sequence B: Level 3 | Experimental | Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily |
|
| irinotecan hydrochloride | Drug |
|
| radiation therapy | Radiation |
|
| Providence Saint Joseph Medical Center - Burbank |
| Burbank |
| California |
| 91505 |
| United States |
| Saint Rose Hospital | Hayward | California | 94545 | United States |
| Valley Memorial Hospital | Livermore | California | 94550 | United States |
| Highland General Hospital at St. George's University School of Medicine | Oakland | California | 94602 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Summit Medical Center | Oakland | California | 94609 | United States |
| J.C. Robinson, M.D. Regional Cancer Center | San Pablo | California | 94806 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19718 | United States |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610 | United States |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida | 33458 | United States |
| Baptist-South Miami Regional Cancer Program | Miami | Florida | 33176 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Wendt Regional Cancer Center at Finley Hospital | Dubuque | Iowa | 52001 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | 48073 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | United States |
| Fox Chase Virtua Health Cancer Program - Marlton | Mount Holly | New Jersey | 08060 | United States |
| AtlantiCare Regional Medical Center | Pomona | New Jersey | 08240 | United States |
| Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown | New York | 10940 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Wayne Radiation Oncology | Goldsboro | North Carolina | 27534 | United States |
| Wilson Medical Center | Wilson | North Carolina | 27893 | United States |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| Mercy Cancer Institute at Mercy Hospital | Pittsburgh | Pennsylvania | 15219 | United States |
| Bon Secours St. Francis Health System | Greenville | South Carolina | 29601 | United States |
| Greenville Hospital System Cancer Center | Greenville | South Carolina | 29605 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| Sarah Cannon Cancer Center at Parkridge Medical Center | Chattanooga | Tennessee | 37404 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84603 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077146 | Irinotecan |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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