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Phase I Study Involving Gadolinium Texaphyrin (NSC 695238) in Patients With Pancreatic and Periampullary Adenocarcinoma Receiving Radiotherapy for Unresectable Disease


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

Phase I Study Involving Gadolinium Texaphyrin (NSC 695238) in Patients With Pancreatic and Periampullary Adenocarcinoma Receiving Radiotherapy for Unresectable Disease


OBJECTIVES: I. Determine the maximum tolerated dose of gadolinium texaphyrin in patients
with locally advanced, unresectable pancreatic or periampullary adenocarcinoma undergoing
local regional radiotherapy. II. Determine the toxic effects of gadolinium texaphyrin with
concurrent radiotherapy in these patients. III. Correlate estimates of tumor and normal
organ gadolinium texaphyrin uptake and retention over time by MRI with plasma/serum levels
in these patients.

OUTLINE: This is a dose escalation study. Patients receive gadolinium texaphyrin IV over
5-10 minutes 4 times weekly at least 2 hours prior to external beam radiotherapy over 2.5
weeks (total of 10 fractions). Cohorts of 3-6 patients are treated at escalating doses of
gadolinium texaphyrin. The maximum tolerated dose is defined as the highest dose level in
which dose limiting toxicity occurs in no more than 2 of 6 patients. Patients are followed
once monthly for 2 months.

PROJECTED ACCRUAL: A total of 45 evaluable patients will be accrued for this study within
18-24 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed locally advanced, unresectable
pancreatic or periampullary adenocarcinoma Patients may have evidence of hepatic or other
intra-abdominal or systemic metastases if they have dominant symptomatology from the
locally unresectable component of disease Prior treatment with 1 chemotherapy regimen
required Palliative bypass procedures without resection allowed Bidimensionally measurable
disease on CT or MRI scan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count
at least 1,500/mm3 Platelet count at least 150,000/mm3 Hemoglobin at least 8.5 g/dL No
history of G6PD deficiency Hepatic: SGOT or SGPT less than 2 times upper limit of normal
(ULN) Alkaline phosphatase less than 2 times ULN Bilirubin no greater than 2.0 mg/dL
(elevated values must be falling or stable for at least 1 week prior to therapy) Renal:
Creatinine no greater than 2.0 mg/dL (no clinical indication of compromised kidney) Other:
Not pregnant or nursing Fertile patients must use effective contraception No second
malignancy within the past 5 years, except: Resected superficial nonmelanomatous skin
cancer Carcinoma in situ of the cervix No uncontrolled or serious medical conditions No
active peptic ulcers No weight loss greater than 5% of ideal body weight within 30 days
prior to study No uncontrolled nausea and vomiting No claustrophobia

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
No concurrent experimental biologic therapy Chemotherapy: See Disease Characteristics
Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy compromising the
delivery of radiation on this study No prior radiotherapy to areas within the planned
field of treatment Surgery: At least 4 weeks since prior gastrointestinal surgery Other:
At least 4 weeks since prior experimental drugs No other concurrent experimental drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ross A. Abrams, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066941, J9840

NCT ID:

NCT00003798

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Johns Hopkins Oncology CenterBaltimore, Maryland  21287