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

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