Combination Chemotherapy Followed by Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003111|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 25, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with irinotecan and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: carboplatin Drug: cisplatin Drug: irinotecan hydrochloride Drug: paclitaxel Procedure: neoadjuvant therapy Procedure: surgical procedure Radiation: radiation therapy||Phase 2|
- Evaluate the efficacy of irinotecan based chemotherapy in patients with stage IIIA non-small cell lung cancer.
- Investigate the phenotypic changes induced in the tumor by this treatment.
OUTLINE: Patients receive IV cisplatin over 30 minutes followed by IV irinotecan over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 3 courses until disease progression. Once potential candidates for resectability are determined, patients undergo thoracotomy or concurrent chemotherapy/radiation therapy within 6 weeks of completing the last course of chemotherapy. Following resection, patients responding to chemotherapy receive 3 additional courses of IV carboplatin and paclitaxel over 3 hours. Patients may undergo local irradiation beginning with the second course of carboplatin and paclitaxel. Chemotherapy ceases if disease remains stable after 8 weeks.
Patients are followed every 3 months for the first year after treatment, then every 6 months thereafter for survival.
PROJECTED ACCRUAL: This study will accrue 20 patients over 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Official Title:||Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC|
|Study Start Date :||April 1997|
|Primary Completion Date :||April 2004|
|Study Completion Date :||April 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003111
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|Study Chair:||John R. Murren, MD||Yale University|