Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Cancer of the Pancreas That Cannot Be Removed by Surgery
|ClinicalTrials.gov Identifier: NCT00003798|
Recruitment Status : Completed
First Posted : August 4, 2004
Last Update Posted : November 14, 2012
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 or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: motexafin gadolinium Radiation: radiation therapy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Official Title:||Phase I Study Involving Gadolinium Texaphyrin (NSC 695238) in Patients With Pancreatic and Periampullary Adenocarcinoma Receiving Radiotherapy for Unresectable Disease|
|Study Start Date :||April 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003798
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21287|
|Study Chair:||Ross A. Abrams, MD||Sidney Kimmel Comprehensive Cancer Center|