Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005065
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2000-04-06
Brief Title:
Chemotherapy Radiation Therapy and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Induction Carboplatin Paclitaxel Chemotherapy Pre-operative Radiotherapy With Gadolinium Texaphyrin Gd-Tex and Surgical Resection in Stage IIIA N2 Non-small Cell Lung Carcinoma
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:
Phase I trial to study the effectiveness of combining carboplatin and paclitaxel radiation therapy with gadolinium texaphyrin and surgery in treating patients who have stage IIIA non-small cell lung cancer 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 Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy Combining chemotherapy radiation therapy and surgery may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine and compare the frequency and grade of toxicities with the use of gadolinium texaphyrin as a radiosensitizer at two dose levels during preoperative radiotherapy in patients with stage IIIA non-small cell lung cancer
II Measure the tumor involved lymph nodes and normal lung concentrations of gadolinium and compare to the image pixel intensity obtained by the 15 Tesla MRI in this patient population given this regimen
OUTLINE This is a dose escalation study of gadolinium texaphyrin Gd-Tex
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours every 3 weeks for 3 courses Three weeks after completion of induction chemotherapy patients receive Gd-Tex IV over 30 minutes twice weekly for 10 doses during preoperative radiotherapy Radiotherapy is administered daily 5 days a week for 5 weeks Approximately 35 weeks after completion of preoperative radiotherapy patients undergo complete surgical resection Three hours prior to surgery patients receive an eleventh dose of Gd-Tex if they do not develop grade 3 or 4 toxicity with the tenth dose Patients also receive a MRI without contrast prior to surgery If the tumor is found to be unresectable patients may receive additional radiation andor chemotherapy
Cohorts of 3-6 patients receive escalating doses of Gd-Tex until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities
Patients are followed at 1 month and then every 4 months for 5 years
I Determine and compare the frequency and grade of toxicities with the use of gadolinium texaphyrin as a radiosensitizer at two dose levels during preoperative radiotherapy in patients with stage IIIA non-small cell lung cancer
II Measure the tumor involved lymph nodes and normal lung concentrations of gadolinium and compare to the image pixel intensity obtained by the 15 Tesla MRI in this patient population given this regimen
OUTLINE This is a dose escalation study of gadolinium texaphyrin Gd-Tex
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours every 3 weeks for 3 courses Three weeks after completion of induction chemotherapy patients receive Gd-Tex IV over 30 minutes twice weekly for 10 doses during preoperative radiotherapy Radiotherapy is administered daily 5 days a week for 5 weeks Approximately 35 weeks after completion of preoperative radiotherapy patients undergo complete surgical resection Three hours prior to surgery patients receive an eleventh dose of Gd-Tex if they do not develop grade 3 or 4 toxicity with the tenth dose Patients also receive a MRI without contrast prior to surgery If the tumor is found to be unresectable patients may receive additional radiation andor chemotherapy
Cohorts of 3-6 patients receive escalating doses of Gd-Tex until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities
Patients are followed at 1 month and then every 4 months for 5 years
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 |
|---|---|---|---|
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |
| OSU 0003 | None | None | None |
| OSU-0003 | None | None | None |
| NCI-T99-0073 | None | None | None |
| OSU-T99-0073 | None | None | None |
| OSU-99H0355 | None | None | None |
| CDR0000067669 | None | None | None |