Lung Cancer Clinical Trial
Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, irinotecan, carboplatin, and etoposide, 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 II trial to study the effectiveness of cisplatin and irinotecan followed by carboplatin, etoposide, and radiation therapy in treating patients who have limited-stage small cell lung cancer.
Full Description
OBJECTIVES:
Primary
Determine the efficacy of cisplatin and irinotecan followed by carboplatin, etoposide, and radiotherapy, in terms of 2-year survival, in patients with limited stage small cell lung cancer.
Secondary
Determine the overall response rate, overall survival, and failure-free survival of patients treated with this regimen.
Determine the response rate in patients treated with induction therapy comprising irinotecan and cisplatin.
Determine the toxicity and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Induction therapy: Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Consolidation therapy: Immediately after the completion of induction therapy, patients receive carboplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Radiotherapy: Beginning on day 1 of consolidation therapy, patients undergo chest radiotherapy daily 5 days a week for 6-7 weeks.
After the completion of consolidation therapy, patients who achieve a complete remission or very good partial remission may undergo prophylactic radiotherapy to the brain.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 15-24 months.
Eligibility Criteria
Histologically or cytologically documented small cell lung cancer of limited stage.
1.1 Limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal lymph nodes.
1.2 Although they are usually defined as having limited stage small cell lung cancer, because of concern about the volume of the radiation field that would be required, patients with clinically suspected or confirmed supraclavicular lymph node metastases, patients with pathologically enlarged contralateral hilar lymph nodes, and patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are NOT eligible.
All Patients must have Measurable Disease
2.1 Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan.
2.2 Pleural/pericardial effusions are not considered measurable.
Age ≥18
ECOG Performance status 0-2.
Prior Treatment - No prior chemotherapy or radiotherapy for SCLC.
No "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
Non-pregnant and non-nursing because of significant risk to the fetus/infant.
Required Initial Laboratory Values
Granulocytes ≥1,500/µl
Platelets ≥100,000/µl
Serum Creatinine ≤ULN
Bilirubin <1.5 mg/dl
SGOT (AST) <2 x ULN
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There are 69 Locations for this study
Lewes Delaware, 19958, United States
Newark Delaware, 19718, United States
Wilmington Delaware, 19805, United States
Washington District of Columbia, 20307, United States
Savannah Georgia, 31403, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Chicago Illinois, 60637, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Hopedale Illinois, 61747, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61603, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Spring Valley Illinois, 61362, United States
Spring Valley Illinois, 61362, United States
Elkhart Indiana, 46515, United States
Fort Wayne Indiana, 46815, United States
La Porte Indiana, 46350, United States
Plymouth Indiana, 46544, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
Iowa City Iowa, 52242, United States
Elkton MD Maryland, 21921, United States
Fall River Massachusetts, 02721, United States
Monroe Michigan, 48162, United States
Minneapolis Minnesota, 55455, United States
Chesterfield Missouri, 63017, United States
Columbia Missouri, 65203, United States
Kansas City Missouri, 64131, United States
St Louis Missouri, 63110, United States
St. Louis Missouri, 63131, United States
Omaha Nebraska, 68114, United States
Keene New Hampshire, 03431, United States
Lebanon New Hampshire, 03756, United States
Rochester New Hampshire, 03867, United States
Camden New Jersey, 08103, United States
Buffalo New York, 14215, United States
Glens Falls New York, 12801, United States
Manhasset New York, 11030, United States
New Hyde Park New York, 11042, United States
Syracuse New York, 13057, United States
Syracuse New York, 13210, United States
Syracuse New York, 13215, United States
Utica New York, 13502, United States
Durham North Carolina, 27710, United States
Gastonia North Carolina, 28053, United States
Goldsboro North Carolina, 27534, United States
Hendersonville North Carolina, 28791, United States
Kinston North Carolina, 28501, United States
Pinehurst North Carolina, 28374, United States
Wilmington North Carolina, 28401, United States
Winston-Salem North Carolina, 27103, United States
Winston-Salem North Carolina, 27157, United States
Columbus Ohio, 43210, United States
Providence Rhode Island, 02903, United States
Providence Rhode Island, 02906, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Danville Virginia, 24541, United States
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