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A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma

Phase 2
18 Years
Open (Enrolling)
Pancreatic Adenocarcinoma

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Trial Information

A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma

The objective of this study are to determine the relapse-free survival of resected
pancreatic cancer patients following two novel regimens. The secondary objectives are 1) to
assess the toxicity of each of these regimens in this setting. 2) To perform exploratory
genomic analyses as a means of assessing molecular characteristics potentially associated
with risk of relapse with one or both of the regimens. 3) To determine the relationship
between known mutations and metabolic activity as measured by FDG-PET and risk of relapse.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed evidence of pancreatic

- Patients must have had all gross disease resected (R0 or R1 resection).

- Patients who underwent an R2 resection are not eligible.

- Patients must have had no prior chemotherapy or radiation therapy for pancreatic

- Age > 18 years.

- Patient must have ECOG performance status of 0-2.

- Patients must have normal organ and marrow function measured within 2 weeks. prior to
registration as follows:

ANC > 1,500/µL Platelets > 100,000/µL Total bilirubim less than 2-fold ULN
AST(SGOT)/ALT(SGPT)<2.5X institutional upper limit of normal Creatinine clearance >
60mL/min for patients with creatinine levels above institutional normal.

- Patients must be > 4 weeks and < 12 weeks post-surgery at time of study registration.

- Women of childbearing potential and sexually active males are stronglt advised to use
appropriate contraceptive measures.

Women must not be pregnant or breast-feeding. All agents used in this study as well as
radiation therapy to the abdomen have the potential for teratogenic or abortifacient
effects. All females of childbearing potential must have a blood test or urine study
within 2 weeks prior to registration to rule out pregnancy.

- Patients must not be receiving any other investigational agents.

- Patients with known metastases are not eligible.

- Patients with wounds that have not fully healed are not eligible.

Exclusion Criteria:


Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Number of Adverse Events

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Peter O'Dwyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Institutional Review Board

Study ID:

UPCC 03213



Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

  • Pancreatic Adenocarcinoma
  • Patients
  • with
  • resected
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283