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A Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin in Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

A Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin in Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma



- To determine the overall 18-month survival of patients with radiographically resectable
pancreatic adenocarcinoma treated with neoadjuvant gemcitabine and oxaliplatin followed
by surgical resection and adjuvant gemcitabine.


- To determine the safety, toxicity, and feasibility of this regimen in the neoadjuvant

- To determine the feasibility of obtaining preoperative core tissue biopsies and the
ability to use these biopsies to establish pathologic correlates of response following
neoadjuvant therapy and to determine if xenografts can be developed from these core

- To determine the specific tumor marker response (CEA and CA19-9) to neoadjuvant

- To determine the prognostic accuracy of serum protein profiles in these patients.

- To determine the overall survival and patterns of tumor recurrence (local vs distant).


- Neoadjuvant therapy: Patients receive gemcitabine IV over 100 minutes and oxaliplatin
IV over 2 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence
of disease progression or unacceptable toxicity.

- Surgery: Within 2-6 weeks after completion of neoadjuvant therapy, patients undergo a
laparoscopy that includes a pancreaticoduodenectomy or distal pancreatectomy with or
without splenectomy.

- Adjuvant therapy: Beginning 4-16 weeks after surgery, patients receive gemcitabine IV
over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 5 courses in
the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative
studies. Samples are analyzed for protein expression and tumor markers (CEA and CA19-9) pre-
and post-neoadjuvant therapy via proteomic analysis. Tumor tissue samples are also banked
for research purposes.

After completion of study treatment, patients are followed every 3 months.

Inclusion Criteria


- Histologically or cytologically confirmed pancreatic adenocarcinoma

- No histology other than adenocarcinoma (e.g., neuroendocrine cancer or acinar

- Patients with adenosquamous variants are eligible

- Radiographically resectable pancreatic cancer, as determined by a surgical oncologist

- No metastatic or locally unresectable pancreatic adenocarcinoma

- No evidence of distant metastases by CT scan

- Negative or pending laparoscopy for distant metastases


- ECOG performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Bilirubin ≤ 4.0 mg/dL (if > 3.0, stented and known to be declining)

- Serum creatinine ≤ 1.6 mg/dL

- INR < 1.5 (therapeutic INR is allowed for patients receiving therapeutic

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study therapy

- No active infection, except for resolving cholangitis, that would preclude study

- Neoadjuvant therapy may only be initiated when acute cholangitis has resolved

- No other malignancy within the past 3 years except for curatively treated basal cell
carcinoma of the skin, cervical intraepithelial neoplasia, or localized prostate
cancer with a PSA of < 5.0 ng/mL within ≥ 4 weeks of study entry (other circumstances
with a recent concurrent or active malignancy will be adjudicated on a case-by-case
basis by the principle investigator [PI] or co-PI)

- No known hypersensitivity to any of the components of oxaliplatin or gemcitabine

- No hypersensitivity to CT scan IV contrast dye not suitable for premedication

- No peripheral neuropathy ≥ grade 2

- No known HIV or hepatitis B or C infection (active, previously treated, or both)

- No other medical condition, including mental illness or substance abuse that, deemed
by the investigator, would preclude study participation


- More than 4 weeks since prior radiotherapy

- No prior radiotherapy to > 25% of bone marrow

- More than 30 days since prior and no other concurrent investigational therapy

- No other prior therapy for pancreatic cancer

- No other concurrent chemotherapy, immunotherapy, or radiotherapy during neoadjuvant

- Concurrent low molecular weight heparin or warfarin, where medically indicated,

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:

Overall survival at 18 months

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Eileen O'Reilly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

October 2013

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage IA pancreatic cancer
  • stage IB pancreatic cancer
  • stage IIA pancreatic cancer
  • stage IIB pancreatic cancer
  • stage III pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021