Status:
WITHDRAWN
A Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.
Lead Sponsor:
Gilead Sciences
Conditions:
Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01510561
Start Date
March 1 2012
End Date
September 1 2015
Last Update
August 19 2021
Active Locations (24)
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1
Banner Healthcare
Gilbert, Arizona, United States, 85234
2
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
3
Christiana Care Health Services Helen Graham Cancer Center
Newark, Delaware, United States, 19713
4
Sylvester Comprehensive Cancer Center Univ. Miami
Miami, Florida, United States, 33136