RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation therapy in treating patients who have cancer of the pancreas that cannot be removed by surgery.

Condition	Treatment or Intervention	Phase
stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas	Drug: gadolinium texaphyrin	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21287,  United States

Study chairs or principal investigators

Ross Allen Abrams,  Study Chair,  Johns Hopkins University   

Study ID Numbers:  CDR0000066941; JHOC-98062407; NCI-T97-0115
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003798
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08