Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin gadolinium may increase the effectiveness of radiation therapy by making tumor cells more sensitive to treatment.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus motexafin gadolinium in treating patients with bile duct, gallbladder, or pancreatic cancer that cannot be removed surgically.
Extrahepatic Bile Duct Cancer
Drug: motexafin gadolinium
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Dose Escalation and Pharmacokinetics Study of the Radiosensitizer, Gadolinium Texaphyrin (Gd-Tex, NSC 695238) With Concurrent Radiotherapy in Advanced Biliary Tree and Pancreatic Cancers|
|Study Start Date:||November 1998|
|Study Completion Date:||June 2002|
|Primary Completion Date:||June 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the safety and toxicity of motexafin gadolinium (PCI-0120) when administered concurrently with radiotherapy in patients with locally advanced unresectable pancreatic or biliary tree tumors. II. Assess the pharmacokinetics of this regimen in these patients. III. Assess tumor uptake of PCI-0120 (by MRI signal characteristics) in these patients. IV. Determine the maximum tolerated dose of PCI-0120 in these patients. V. Determine the objective response (by radiologic criteria) in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120). Patients receive PCI-0120 IV over 15 minutes 3 times weekly concurrently with external beam radiotherapy (EBRT) 5 days a week for 5.5 weeks. After completion of EBRT and PCI-0120, patients may undergo radiotherapy boost for 5 consecutive days. Cohorts of 3-6 patients receive escalating doses of PCI-0120 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 toxicity. A total of 6-12 patients are treated at the recommended phase II dose. The recommended phase II dose is defined as the dose immediately preceding the MTD. Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 18-21 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003411
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213-3489|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Study Chair:||Ramesh K. Ramanathan, MD||University of Pittsburgh|