Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003202
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
1999-11-01
Brief Title:
Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Alternating Phase III Trials of Twice-Weekly Infusion Gemcitabine 22-Difluoro-2-Deoxycytidine and Concurrent Thoracic Radiation Alone - Or Following 2 Cycles of CisplatinGemcitabine Induction Chemotherapy for the Treatment of Stage IIIAIIIB Non Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2018-08
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase III trial to compare the effectiveness of gemcitabine with radiation therapy alone or following two-drug combination chemotherapy in treating patients with stage III non-small cell lung cancer
PURPOSE Phase III trial to compare the effectiveness of gemcitabine with radiation therapy alone or following two-drug combination chemotherapy in treating patients with stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy alone or following 2 cycles of induction chemotherapy in patients with Stage IIIA or IIIB non-small cell lung cancer
Assess the toxicity of concurrent thoracic radiation and gemcitabine in these patients
Determine the effectiveness of concurrent radiation and gemcitabine by determining the complete response rate partial response rate time to recurrence pattern of recurrence and overall survival in a cohort of these patients
OUTLINE This is an alternating two arm dose escalation multicenter study
Arm I Patients receive twice-weekly gemcitabine as a 30 minute infusion Concurrent radiation therapy is administered 5 days a week for 6 weeks
Arm II Patients receive 2 cycles of induction chemotherapy consisting of gemcitabine as a 30 minute infusion on day 1 and 8 and cisplatin IV over 1 hour on day 1 Each cycle is 21 days Patients then receive gemcitabine and radiation therapy as in arm I
Cohorts of 3 patients are enrolled into each treatment arm at each dose level of gemcitabine Toxicity for each arm is assessed independently Once dose limiting toxicity DLT is observed at any dose level 3 more patients are enrolled at the same dose level The maximum tolerated dose MTD is defined as the dose at which no more than 1 of 6 patients experiences grade 4 toxicity or no more than 4 of 6 patients experience grade 3 or worse toxicity DLT After the MTD is determined for each treatment arm additional patients are treated at that dose level for the phase II portion of the study
Patients are followed every 3 months for 2 years then every 4 months for the next 2 years and then every 6 months thereafter
PROJECTED ACCRUAL There will be approximately 24-48 patients accrued into this study within 1-2 years
Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy alone or following 2 cycles of induction chemotherapy in patients with Stage IIIA or IIIB non-small cell lung cancer
Assess the toxicity of concurrent thoracic radiation and gemcitabine in these patients
Determine the effectiveness of concurrent radiation and gemcitabine by determining the complete response rate partial response rate time to recurrence pattern of recurrence and overall survival in a cohort of these patients
OUTLINE This is an alternating two arm dose escalation multicenter study
Arm I Patients receive twice-weekly gemcitabine as a 30 minute infusion Concurrent radiation therapy is administered 5 days a week for 6 weeks
Arm II Patients receive 2 cycles of induction chemotherapy consisting of gemcitabine as a 30 minute infusion on day 1 and 8 and cisplatin IV over 1 hour on day 1 Each cycle is 21 days Patients then receive gemcitabine and radiation therapy as in arm I
Cohorts of 3 patients are enrolled into each treatment arm at each dose level of gemcitabine Toxicity for each arm is assessed independently Once dose limiting toxicity DLT is observed at any dose level 3 more patients are enrolled at the same dose level The maximum tolerated dose MTD is defined as the dose at which no more than 1 of 6 patients experiences grade 4 toxicity or no more than 4 of 6 patients experience grade 3 or worse toxicity DLT After the MTD is determined for each treatment arm additional patients are treated at that dose level for the phase II portion of the study
Patients are followed every 3 months for 2 years then every 4 months for the next 2 years and then every 6 months thereafter
PROJECTED ACCRUAL There will be approximately 24-48 patients accrued into this study within 1-2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
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 |
|---|---|---|---|
| CCCWFU-62197 | None | None | None |
| NCI-G98-1386 | None | None | None |