Overview

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

Status:
Completed

Trial end date:
2002-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Pittsburgh

Collaborator:

National Cancer Institute (NCI)

Treatments:

Motexafin gadolinium

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