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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ramesh K. Ramanathan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Federal Government

Study ID:

CDR0000066423

NCT ID:

NCT00003411

Start Date:

November 1998

Completion Date:

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Pancreatic Cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • unresectable gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms

Name

Location
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792