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Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
motexafin gadolinium
radiation therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring stage II pancreatic cancer, stage III pancreatic cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced, unresectable carcinoma of the biliary tree or pancreas Metastatic disease allowed on a case by case basis provided the following criteria exists: Minimal or low volume disease Need for palliative radiotherapy to primary tumor with or without motexafin gadolinium No requirement for systemic therapy Measurable disease in at least 2 dimensions No ascites requiring therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 No history of glucose-6-phosphate dehydrogenase deficiency Hepatic: Bilirubin no greater than 2.0 mg/dL AST and ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 1.6 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of porphyria No active infection No physical or psychological illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to primary site of tumor Surgery: See Disease Characteristics At least 3 weeks since prior major surgery Other: At least 4 weeks since prior investigational drugs No other concurrent investigational antineoplastic drugs

Sites / Locations

  • Norris Cotton Cancer Center
  • University of Pittsburgh Cancer Institute
  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 15, 2016
Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003411
Brief Title
Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Pancreatic Cancer
Keywords
stage II pancreatic cancer, stage III pancreatic cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
motexafin gadolinium
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced, unresectable carcinoma of the biliary tree or pancreas Metastatic disease allowed on a case by case basis provided the following criteria exists: Minimal or low volume disease Need for palliative radiotherapy to primary tumor with or without motexafin gadolinium No requirement for systemic therapy Measurable disease in at least 2 dimensions No ascites requiring therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 No history of glucose-6-phosphate dehydrogenase deficiency Hepatic: Bilirubin no greater than 2.0 mg/dL AST and ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 1.6 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of porphyria No active infection No physical or psychological illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to primary site of tumor Surgery: See Disease Characteristics At least 3 weeks since prior major surgery Other: At least 4 weeks since prior investigational drugs No other concurrent investigational antineoplastic drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramesh K. Ramanathan, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Chair
Facility Information:
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-3489
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer

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