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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003411
• Other study ID #: PCI-97-108
• Secondary ID: CDR0000066423NCI
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: January 15, 2016
• Start date: November 1998
• Est. completion date: June 2002

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2002
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma
• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• motexafin gadolinium

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,