Working… Menu

Safety and Efficacy Study of Different Doses of 90Y-hPAM4 Combined With Gemcitabine in Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603863
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : January 23, 2014
Information provided by (Responsible Party):
Immunomedics, Inc.

Brief Summary:
This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination with gemcitabine in patients with previously untreated pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: IMMU-107 (hPAM4) Phase 1 Phase 2

Detailed Description:
Patients receive a 4-week treatment cycle with once-weekly 30-minute gemcitabine infusions beginning one week prior to the first 90Y-hPAM4dose and continuing during the 3 consecutive weeks over which once weekly 90Y-hPAM4 doses are given. Depending on toxicity, patient cohorts will receive one of several possible 90Y and gemcitabine dose combinations. Post-treatment evaluations conducted until instituting another 90YhPAM4 treatment cycle, maintenance gemcitabine or for a maximum period of 12 weeks.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Patients With Previously Untreated Advanced Pancreatic Cancer.
Study Start Date : January 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: multiple dose levels
1 of 3 different dose levels of 90Y-hPAM4 given once weekly for 3 weeks along with 4 weekly doses of gemcitabine.
Biological: IMMU-107 (hPAM4)
90Y-hPAM4 once weekly for 3 weeks gemcitabine once weekly for 4 weeks
Other Names:
  • hPAM4
  • IMMU-107
  • 90Y-hPAM4
  • anti-mucin antibody

Primary Outcome Measures :
  1. safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity [ Time Frame: over 12 weeks ]

Secondary Outcome Measures :
  1. Efficacy and Clinical benefit measures such as quality of life, pain assessments, etc. [ Time Frame: over 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 III (locally advanced, unresectable) or Stage IV (metastatic) disease, including patients who underwent surgery but had incomplete resections.
  • Treatment naïve (no prior chemotherapy, radiotherapy or investigational agents for pancreatic cancer)
  • Karnofsky performance status > 70 % (Appendix A).
  • Expected survival > 3 months.
  • At least 4 weeks beyond major surgery and recovered from all acute toxicities
  • 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 > 11 g/dL, ANC > 2,000 per mm3, platelets > 150,000 per mm3)
  • Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN)
  • Otherwise, all toxicity at study entry <Grade 1 by NCI CTC v3.0.

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 anorexia, 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 5-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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00603863

Layout table for location information
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
United States, Florida
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Herbert Werthem College of Medicine/Jackson North Medical Center
Miami, Florida, United States, 33169
Moffit Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute/Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Indiana
Goshen Cancer Center
Goshen, Indiana, United States, 46526
United States, New York
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States, 10021
Mt. Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Thomas Jefferson University Medical Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Immunomedics, Inc.
Layout table for investigator information
Study Chair: William Wegener, MD, PHD Immunomedics, Inc.


Layout table for additonal information
Responsible Party: Immunomedics, Inc. Identifier: NCT00603863     History of Changes
Other Study ID Numbers: IM-T-hPAM4-02
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014
Keywords provided by Immunomedics, Inc.:
pancreatic cancer
MUC1 antibody
cancer of the pancreas
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs