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A Phase Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Patients With Previously Untreated Advanced Pancreatic Cancer.

Phase 1/Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

A Phase Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Patients With Previously Untreated Advanced Pancreatic Cancer.

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.

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

- 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
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

- Known metastatic disease to the central nervous system.

- Presence of bulky disease (defined as any single mass >10 cm in its greatest

- Patients with >Grade 2 anorexia, nausea or vomiting, and/or signs of intestinal

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity

Outcome Time Frame:

over 12 weeks

Safety Issue:


Principal Investigator

William Wegener, MD, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • hPAM4
  • MUC1 antibody
  • cancer of the pancreas
  • Pancreatic Neoplasms



University of North Carolina Chapel Hill, North Carolina  27599
Ohio State University Medical Center Columbus, Ohio  43210
Sylvester Comprehensive Cancer Center Miami, Florida  
Mt. Sinai Medical Center New York, New York  10029
Christiana Care Health Services Newark, Delaware  19713
Moffit Cancer Center Tampa, Florida  33612
Goshen Cancer Center Goshen, Indiana  46526
Herbert Werthem College of Medicine/Jackson North Medical Center Miami, Florida  33169
Winship Cancer Institute/Emory University Hospital Atlanta, Georgia  30322
New York Presbyterian Hospital/Weill Cornell Medical Center New York, New York  10021
Thomas Jefferson University Medical Center Philadelphia, Pennsylvania  19107