Combination Chemotherapy as Induction Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00003037|
Recruitment Status : Completed
First Posted : November 25, 2003
Last Update Posted : June 27, 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 I/II trial to study the effectiveness of combination chemotherapy with docetaxel, gemcitabine, and cisplatin as induction therapy in treating patients with stage III non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride||Phase 1 Phase 2|
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and schedule of docetaxel, gemcitabine, and cisplatin as induction chemotherapy in patients with Stage III non-small cell lung cancer (NSCLC) scheduled to undergo subsequent surgical resection or irradiation. II. Determine the major objective response rate of this combination therapy in these patients.
OUTLINE: This is a dose escalation study. Docetaxel in administered as a 1 hour IV infusion at week 1, 5, and 9. Gemcitabine is administered as a 30 minute IV infusion at weeks 1, 2, 3, 5, 6, 7, 9, 10, and 11. Cisplatin is administered as a 20 minute IV infusion at weeks 3, 7, and 11. In addition, G-CSF is administered subcutaneously on days 2 through 6 of each 28 day cycle following each dose of docetaxel. Three patients are entered at each dose level and must complete one cycle of therapy. If no patient experiences dose limiting toxicity (DLT), then 3 patients are treated at the next higher dose level. If 1 patient experiences DLT, then 3 more patients are treated at that same dose level. If 2 of 6 patients experience DLT, then that dose is declared the maximum tolerated dose (MTD). Once the MTD is determined, the Phase II portion of the study begins and additional patients are treated at the dose level just below the MTD. Patients who show complete or partial response, or no change, after chemotherapy, undergo surgical resection or radiotherapy to remove or reduce their tumor. Patients are assessed for disease progression and unacceptable toxicities every 4 weeks till end of treatment.
PROJECTED ACCRUAL: An estimated 40 patients will be accrued in this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I/II Trial of the Combination of Docetaxel, Gemcitabine and Cisplatin (DGP) as Induction Chemotherapy in Patients With Stage III Non-Small Cell Lung Cancer|
|Study Start Date :||April 1997|
|Primary Completion Date :||March 2002|
|Study Completion Date :||March 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003037
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Jorge Gomez, MD||Memorial Sloan Kettering Cancer Center|