Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003037
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy as Induction Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase III Trial of the Combination of Docetaxel Gemcitabine and Cisplatin DGP as Induction Chemotherapy in Patients With Stage III Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 III 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
PURPOSE Phase III 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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G97-1285 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065659 | REGISTRY | None | None |