A Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.
NCT ID: NCT01510561
Last Updated: 2021-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2012-03-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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90Y-hPAM4
90Y-hPAM4 is administered weekly for 3 weeks
90Y-hPAM4
90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4.
90Y-hPAM4
90Y-hPAM4 + gemcitabine
90Y-hPAM4 is administered weekly for 3 weeks, while gemcitabine is administered weekly for 4 weeks.
90Y-hPAM4
90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4.
90Y-hPAM4
90Y-hPAM4 + gemcitabine
Interventions
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90Y-hPAM4
90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4.
90Y-hPAM4
90Y-hPAM4 + gemcitabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed pancreatic adenocarcinoma
* Stage IV (metastatic) disease, including patients who underwent surgery but had incomplete resections
* Previously treated and received two prior treatment regimens for advanced disease
* Karnofsky performance status ≥ 60 % (Appendix A)
* Expected survival ≥ 3 months
* At least 4 weeks beyond major surgery, 2 weeks beyond chemotherapy, radiotherapy, other experimental treatments
* At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis
* Adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dL, ANC \> 1,500 per mm3, platelets \> 100,000 per mm3)
* Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN \[5.0 X IULN if due to liver metastases\])
* Otherwise, all toxicity at study entry ≤ Grade 1 by NCI CTC v3.0 or recovered to baseline or discussed with and agreed to with Immunomedics' Medical Monitor.
Exclusion Criteria
* Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period
* Known metastatic disease to the central nervous system
* Presence of bulky disease (defined as any single mass \> 10 cm in its greatest dimension)
* Patients with \> Grade 2 nausea or vomiting and/or signs of intestinal obstruction
* Prior radiation dose \> 3,000 cGy to the liver, \> 2,000 cGy to lungs and kidneys or prior external beam irradiation to a field that includes more than 30% of the red marrow
* Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 3-year disease free interval
* Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive
* Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months, or cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy
* Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months
* Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids)
* Infection requiring intravenous antibiotic use within 1 week
* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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William A Wegener, MD, PhD
Role: STUDY_CHAIR
Gilead Sciences
Locations
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Banner Healthcare
Gilbert, Arizona, United States
Scottsdale Healthcare
Scottsdale, Arizona, United States
Christiana Care Health Services Helen Graham Cancer Center
Newark, Delaware, United States
Sylvester Comprehensive Cancer Center Univ. Miami
Miami, Florida, United States
Jackson North Medical Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Mountain States Tumor Institute
Boise, Idaho, United States
Goshen Center for Cancer Care
Goshen, Indiana, United States
Detroit Clinical Research Center
Detroit, Michigan, United States
St. Mary's Trinity Healthcare
Grand Rapids, Michigan, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Weill Cornell NY Presbyterian Hospital
New York, New York, United States
Mt. Sinai Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Kimmel Cancer Center at Jefferson University
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Institute of Translational Oncology Research
Greenville, South Carolina, United States
Tyler Cancer Center
Tyler, Texas, United States
VA Oncology Associates
Norfolk, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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References
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Picozzi VJ, Ramanathan RK, Lowery MA, Ocean AJ, Mitchel EP, O'Neil BH, Guarino MJ, Conkling PR, Cohen SJ, Bahary N, Frank RC, Dragovich T, Bridges BB, Braiteh FS, Starodub AN, Lee FC, Gribbin TE, Richards DA, Lee M, Korn RL, Pandit-Taskar N, Goldsmith SJ, Intenzo CM, Sheikh A, Manzone TC, Horne H, Sharkey RM, Wegener WA, O'Reilly EM, Goldenberg DM, Von Hoff DD. (90)Y-clivatuzumab tetraxetan with or without low-dose gemcitabine: A phase Ib study in patients with metastatic pancreatic cancer after two or more prior therapies. Eur J Cancer. 2015 Sep;51(14):1857-64. doi: 10.1016/j.ejca.2015.06.119. Epub 2015 Jul 14.
Other Identifiers
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IM-T-hPAM4-03
Identifier Type: -
Identifier Source: org_study_id
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