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Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer Clinical research trials and Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer. Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer clinical trial. Subjects frequently get the best healthcare possible for their Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer  Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
For Condition: unresectable extrahepatic bile duct cancer,stage 4A pancreatic cancer,stage 3 pancreatic cancer,stage 4B pancreatic cancer,stage 2 pancreatic cancer,unresectable gallbladder cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Pittsburgh Cancer Institute
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gadolinium texaphyrin may increase the effectiveness of radiation therapy by making tumor cells more sensitive to treatment. PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus gadolinium texaphyrin in treating patients with bile duct, gallbladder, or pancreatic cancer that cannot be removed surgically.
Details: OBJECTIVES: I. Define the safety and toxicity of gadolinium texaphyrin (Gd-Tex) when given concurrently with radiation therapy (RT) 3 times weekly for 16 doses, in patients with locally advanced unresectable pancreatic and biliary tree tumors. II. Evaluate the pharmacokinetics of this treatment on this schedule in these patients. III. Assess tumor uptake of Gd-Tex in these patients. IV. Determine a maximum tolerated dose of Gd-Tex in these patients. V. Evaluate the objective response to Gd-Tex administration with RT in these patients. PROTOCOL OUTLINE: This is a dose escalation study of gadolinium texaphyrin (Gd-Tex). Patients receive IV Gd-Tex 3 times weekly by IV injection over 15 minutes with concurrent external beam radiation therapy (RT) over 5.5 weeks (total of 16 doses; RT is delivered 5 days a week for a total of 28 fractions). In the absence of dose limiting toxicity (DLT) in the first cohort of 3 patients treated, subsequent cohorts each receive escalating doses on the same schedule. If DLT is observed in 2 of 3 patients or 2 of 6 patients at a given dose level, then dose escalation ceases and that dose is declared the maximum tolerated dose (MTD), and the next lower dose is declared the recommended dose for phase II studies. Patient1s are followed at 4 weeks after the end of RT. PROJECTED ACCRUAL: Approximately 28-31 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 gadolinium texaphyrin; Systemic therapy no longer required - Measurable disease in at least 2 dimensions --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to primary site of tumor - Surgery: At least 3 weeks since major surgery - Other: At least 4 weeks since other prior investigational drugs; No other concurrent investigational drugs --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 G6PD deficiency - Hepatic: Bilirubin no greater than 2.0 mg/dL; AST and ALT no greater than 1.5 times upper limit of normal - Renal: Creatinine less than 1.6 mg/dL - Other: Not pregnant or nursing; Effective contraception required of fertile patients; No history of porphyria; No active infection; No ascites requiring therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RameshRamanathan, Study Chair, University of Pittsburgh Cancer Institute
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Additional Information:
Study ID Numbers: CDR0000066423; PCI-97-108,NCI-T97-0109
Study Start Date: July 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003411
Other Stage 4b Pancreatic Cancer Studies:
1. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer
2. Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
3. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
4. Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
5. Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
Related Studies:
Other stage 4B pancreatic cancer Clinical Trials
Other New Hampshire Clinical Trials
Other Lebanon Clinical Trials
Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
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