Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004093
Status:
TERMINATED
Last Update Posted:
2012-06-06
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase I-II Study of Induction Chemotherapy With Carboplatin and Gemcitabine Followed by Chemoradiotherapy With Paclitaxel and Vinorelbine for Patients With Locally Advanced Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Original Principal Investigator left the institution
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy and radiation therapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage III non-small cell lung cancer
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the feasibility of the concurrent chemoradiotherapy regimen of paclitaxel and vinorelbine with standard chest radiotherapy in patients with locally advanced non-small cell lung cancer II Determine the maximum tolerated dose and dose limiting toxicities of this regimen in this patient population III Determine the radiologic response rate of induction chemotherapy with carboplatin and gemcitabine in this patient population IV Evaluate the pathologic response rate in patients undergoing resection V Evaluate the time to progression overall survival and quality of life in this patient population
OUTLINE This is a dose escalation study of vinorelbine Patients receive induction chemotherapy consisting of carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks for 2 courses At 2 weeks following completion of induction chemotherapy patients receive vinorelbine IV over 10 minutes followed by paclitaxel IV over 60 minutes weekly and radiotherapy daily for 5 consecutive days a week on weeks 1-6 Following initial induction chemotherapy patients with stable or regressive disease may receive an additional 2-4 courses of carboplatin and gemcitabine at investigators discretion At approximately 2-6 weeks following completion of chemoradiotherapy patients with resectableoperable disease undergo surgical resection Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose limiting toxicity Quality of life is assessed in all patients Patients are followed at 1 month
PROJECTED ACCRUAL A total of 38-47 patients will be accrued for this study within 12-18 months
OUTLINE This is a dose escalation study of vinorelbine Patients receive induction chemotherapy consisting of carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks for 2 courses At 2 weeks following completion of induction chemotherapy patients receive vinorelbine IV over 10 minutes followed by paclitaxel IV over 60 minutes weekly and radiotherapy daily for 5 consecutive days a week on weeks 1-6 Following initial induction chemotherapy patients with stable or regressive disease may receive an additional 2-4 courses of carboplatin and gemcitabine at investigators discretion At approximately 2-6 weeks following completion of chemoradiotherapy patients with resectableoperable disease undergo surgical resection Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose limiting toxicity Quality of life is assessed in all patients Patients are followed at 1 month
PROJECTED ACCRUAL A total of 38-47 patients will be accrued for this study within 12-18 months
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-G99-1585 | None | None | None |
| NU-99L1 | None | None | None |