Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016315
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2001-05-06
Brief Title:
Gemcitabine Carboplatin or Paclitaxel Plus Radiation Therapy in Treating Patients With Stage IIIA or IIIB Non-Small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase I Study of Gemcitabine Carboplatin or Gemcitabine Paclitaxel and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients With Favorable Prognosis Inoperable Stage IIIAB Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2015-11
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 such as gemcitabine carboplatin and paclitaxel work in 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 I trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of gemcitabine when administered with carboplatin and thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in patients with stage IIIA or IIIB non-small cell lung cancer
Determine the MTD of gemcitabine and paclitaxel when administered with thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in these patients
OUTLINE This is a multicenter dose-escalation study of gemcitabine and paclitaxel Patients are sequentially assigned to 1 of 3 treatment regimens
Regimen A Patients receive gemcitabine IV over 30-60 minutes on days 1 8 22 29 and 43 and thoracic radiotherapy daily 5 days a week for 7 weeks beginning on day 1
Regimen B closed to accrual as of 51303 Patients receive gemcitabine and thoracic radiotherapy as in regimen A and carboplatin IV over 30 minutes on days 1 8 22 29 and 43
Regimen C Patients receive gemcitabine and thoracic radiotherapy as in regimen A and paclitaxel IV over 1 hour on days 1 8 22 29 and 43
At 3 weeks after completion of chemoradiotherapy all patients receive adjuvant gemcitabine IV over 30-60 minutes on days 71 78 92 and 99 and carboplatin IV over 30 minutes on days 71 and 92
The first 6 patients enrolled receive regimen A to determine the safety of the initial dose of gemcitabine After completion of regimen A cohorts of 3-6 patients receive escalating doses of gemcitabine in regimen B closed to accrual as of 51303 until the maximum tolerated dose MTD is determined In a separate sequence cohorts of 3-6 patients receive alternating escalating doses of gemcitabine and paclitaxel in regimen C until the MTD is determined The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 months 6 months every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 78 patients will be accrued for this study within 29 months
Determine the maximum tolerated dose MTD of gemcitabine when administered with carboplatin and thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in patients with stage IIIA or IIIB non-small cell lung cancer
Determine the MTD of gemcitabine and paclitaxel when administered with thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in these patients
OUTLINE This is a multicenter dose-escalation study of gemcitabine and paclitaxel Patients are sequentially assigned to 1 of 3 treatment regimens
Regimen A Patients receive gemcitabine IV over 30-60 minutes on days 1 8 22 29 and 43 and thoracic radiotherapy daily 5 days a week for 7 weeks beginning on day 1
Regimen B closed to accrual as of 51303 Patients receive gemcitabine and thoracic radiotherapy as in regimen A and carboplatin IV over 30 minutes on days 1 8 22 29 and 43
Regimen C Patients receive gemcitabine and thoracic radiotherapy as in regimen A and paclitaxel IV over 1 hour on days 1 8 22 29 and 43
At 3 weeks after completion of chemoradiotherapy all patients receive adjuvant gemcitabine IV over 30-60 minutes on days 71 78 92 and 99 and carboplatin IV over 30 minutes on days 71 and 92
The first 6 patients enrolled receive regimen A to determine the safety of the initial dose of gemcitabine After completion of regimen A cohorts of 3-6 patients receive escalating doses of gemcitabine in regimen B closed to accrual as of 51303 until the maximum tolerated dose MTD is determined In a separate sequence cohorts of 3-6 patients receive alternating escalating doses of gemcitabine and paclitaxel in regimen C until the MTD is determined The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 months 6 months every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 78 patients will be accrued for this study within 29 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 |
|---|---|---|---|
| CDR0000068622 | None | None | None |
| RTOG-L-0017 | None | None | None |