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.
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 1.5 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
3.5 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 and/or 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose, defined as that dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT) graded according to CTC version 2.0
Up to day 119
Ohio State University
United States: Food and Drug Administration
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|