Status:
COMPLETED
Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 us...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Histologically or cytologically documented small cell lung cancer of limited stage.
- 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.
- 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
- 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 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
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00072527
Start Date
November 1 2003
End Date
January 1 2013
Last Update
July 6 2016
Active Locations (76)
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1
Beebe Medical Center
Lewes, Delaware, United States, 19958
2
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19718
3
St. Francis Hospital
Wilmington, Delaware, United States, 19805
4
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307