Status:
COMPLETED
ADH-1, Gemcitabine Hydrochloride & Cisplatin in Treating Metastatic Pancreatic or Biliary Tract Cancer
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
Adherex Technologies, Inc.
National Cancer Institute (NCI)
Conditions:
Ampulla of Vater Adenocarcinoma
Gallbladder Adenocarcinoma
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of ADH-1 when given together with gemcitabine hydrochloride and cisplatin in treating patients with pancreatic or biliary tract cancer that ha...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the toxicities and determine the recommended dose of ADH-1 given twice weekly for 3 weeks in combination with cisplatin and fixed-dose rate gemcitabine (gemcitabine...
Eligibility Criteria
Inclusion
- Patients must have adenocarcinoma of the pancreas or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder or ampulla of Vater) that is locally advanced, but non-resectable, metastatic or residual disease after attempted surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or better
- Absolute neutrophil count (ANC) of 2000 per mcL or higher
- Platelet count of 100,000 per mcL or higher
- Patients must have a serum creatinine that is at or below the upper limits of the institutional normal range OR a creatinine clearance of 60 mL per min or higher corrected for body surface area (BSA)
- The total bilirubin must be at or below 2.0 mg/dL in the absence of biliary obstruction; if the patient has biliary obstruction, biliary decompression will be required; either endoscopic placement of a biliary stent or percutaneous transhepatic drainage is acceptable; once biliary drainage has been established, institution of protocol therapy may proceed when the total bilirubin falls to 3.0 mg/dL or lower
- Patients need not have measurable disease for this study
- The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
- Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
- Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study; (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
Exclusion
- Patients may not have received prior chemotherapy for metastatic adenocarcinoma of the pancreas or biliary tract; prior adjuvant chemotherapy is acceptable provided that 6 months or longer has elapsed since completion of the prior therapy
- History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
- Uncontrolled inter-current illness including, but not limited to ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia, that might jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety
- Pregnant and nursing women are excluded from this study
- Patients with prior malignancy will be excluded except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 years
Key Trial Info
Start Date :
April 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01825603
Start Date
April 9 2013
End Date
June 1 2017
Last Update
December 28 2023
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198