Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003411
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
1999-11-01
Brief Title:
Radiation Therapy in Treating Patients With Bile Duct Gallbladder or Pancreatic Cancer
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-01
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 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
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
Detailed Description:
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 55 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
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 55 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
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 |
|---|---|---|---|
| NCI-T97-0109 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066423 | REGISTRY | None | None |