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.

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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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

78

Study ID:

NCT00072527

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 69 Locations for this study

See Locations Near You

Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19718, United States
St. Francis Hospital
Wilmington Delaware, 19805, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia, 31403, 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 Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Eureka 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
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
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne Indiana, 46815, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Saint Joseph Regional Medical Center - Plymouth Campus
Plymouth Indiana, 46544, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
Union Hospital Cancer Center at Union Hospital
Elkton MD Maryland, 21921, United States
Hudner Oncology Center at Saint Anne's Hospital
Fall River Massachusetts, 02721, United States
Mercy Memorial Hospital System
Monroe Michigan, 48162, United States
Fairview University Medical Center - University Campus
Minneapolis Minnesota, 55455, United States
Saint Luke's Hospital
Chesterfield Missouri, 63017, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri, 65203, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis Missouri, 63110, United States
Missouri Baptist Cancer Center
St. Louis Missouri, 63131, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha Nebraska, 68114, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene New Hampshire, 03431, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Frisbie Memorial Hospital
Rochester New Hampshire, 03867, United States
Cancer Institute of New Jersey at the Cooper University Hospital
Camden New Jersey, 08103, United States
Veterans Affairs Medical Center - Buffalo
Buffalo New York, 14215, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls New York, 12801, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park New York, 11042, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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
Comprehensive Cancer Center at Gaston Memorial
Gastonia North Carolina, 28053, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Pardee Memorial Hospital
Hendersonville North Carolina, 28791, United States
Lenoir Memorial Cancer Center
Kinston North Carolina, 28501, United States
Comprehensive Cancer Center at Moore Regional Hospital
Pinehurst North Carolina, 28374, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington North Carolina, 28401, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem North Carolina, 27103, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus Ohio, 43210, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Miriam Hospital at Lifespan
Providence Rhode Island, 02906, 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
Danville Regional Medical Center
Danville Virginia, 24541, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

78

Study ID:

NCT00072527

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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