Clinical trial NCT01510561: A Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.
Official title: A Ph Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer
Metastatic Pancreatic Cancer
Keywords: metastatic pancreatic adenocarcinoma
pancreatic cancer
metastatic pancreatic cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 90Y-hPAM4 is administered weekly for 3 weeks combined with 4 weekly doses of gemcitabine to assess. This is a dose escalation study of 90Y-hPAM4 to assess which dose is safe and effective as 3rd line treatment for patients with metastatic pancreatic cancer. Patients are then followed weekly for 12 weeks and afterwards for up to 1 year.


Eligibility criteria: Inclusion Criteria:

* Male or female patients, ≥ 18 years of age, who are able to understand and give written informed consent
* 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 who are pregnant or lactating
* 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

Primary outcomes:
measure: Safety (change in hematology and chemistry laboratory values from baseline)
timeFrame: 1 year
Secondary outcomes:
measure: Dosage determination
timeFrame: 2 years
measure: Efficacy
timeFrame: 1 year
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner Healthcare
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Newark
country: United States
facility: Christiana Care Health Services Helen Graham Cancer Center
state: Delaware
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center Univ. Miami
state: Florida
city: Miami
country: United States
facility: Jackson North Medical Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Boise
country: United States
facility: Mountain States Tumor Institute
state: Idaho
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Detroit
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Grand Rapids
country: United States
facility: St. Mary's Trinity Healthcare
state: Michigan
city: Albuquerque
country: United States
facility: New Mexico Cancer Care Alliance
state: New Mexico
city: New York
country: United States
facility: Weill Cornell NY Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hillman Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Institute of Translational Oncology Research
state: South Carolina
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Norfolk
country: United States
facility: VA Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Gilead Sciences
name: William A Wegener, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.