A Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.

Pancreatic Cancer Clinical Trial

Official title:

A Ph Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01510561
• Other study ID #: IM-T-hPAM4-03
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 2012
• Est. completion date: September 2015

Study information

• Verified date: December 2020
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma
• Metastatic Pancreatic Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	New Mexico Cancer Care Alliance	Albuquerque	New Mexico
United States	Winship Cancer Institute	Atlanta	Georgia
United States	Mountain States Tumor Institute	Boise	Idaho
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Detroit Clinical Research Center	Detroit	Michigan
United States	Banner Healthcare	Gilbert	Arizona
United States	Goshen Center for Cancer Care	Goshen	Indiana
United States	St. Mary's Trinity Healthcare	Grand Rapids	Michigan
United States	Institute of Translational Oncology Research	Greenville	South Carolina
United States	Jackson North Medical Center	Miami	Florida
United States	Sylvester Comprehensive Cancer Center Univ. Miami	Miami	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Mt. Sinai Medical Center	New York	New York
United States	Weill Cornell NY Presbyterian Hospital	New York	New York
United States	Christiana Care Health Services Helen Graham Cancer Center	Newark	Delaware
United States	VA Oncology Associates	Norfolk	Virginia
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Jefferson University	Philadelphia	Pennsylvania
United States	Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida
United States	Tyler Cancer Center	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (change in hematology and chemistry laboratory values from baseline)	Acute safety will be assessed weekly for the 1st 12 weeks, and then for up to 1 year after completion of study drug treatment. Safety will be assessed by comparing baseline hematology and chemistry laboratory values with the values obtained weekly after treatment. Safety will also be assessed by the adverse events that are reported.	1 year
Secondary	Dosage determination	This study is also being done to determine an acceptable 90Y-hPAM4 dose in this patient population. It is anticipated that enrollment will occur over 2 years.	2 years
Secondary	Efficacy	Efficacy will be assessed for at least 1 year after treatment with study drug. CT scans will be used to determine treatment response.	1 year