Gemcitabine And Oxaliplatin In Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

Study Overview

Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with pancreatic cancer that can be removed by surgery.

OBJECTIVES: Primary * 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. Secondary * To determine the safety, toxicity, and feasibility of this regimen in the neoadjuvant setting. * 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 tissues. * To determine the specific tumor marker response (CEA and CA19-9) to neoadjuvant therapy. * 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). OUTLINE: * 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.

Pancreatic Cancer

DRUG: gemcitabine hydrochloride
DRUG: oxaliplatin
GENETIC: protein expression analysis
GENETIC: proteomic profiling
OTHER: diagnostic laboratory biomarker analysis
PROCEDURE: adjuvant therapy
PROCEDURE: neoadjuvant therapy
PROCEDURE: therapeutic conventional surgery

07-113
MSKCC-07113

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-09-27	Results First Submitted 2013-11-27	Last Update Submitted that met QC Criteria 2017-02-07
First Submitted that Met QC Criteria 2007-09-27	Results First Submitted that Met QC Criteria 2015-11-16	Last Update Posted (ACTUAL) 2017-03-16
First Posted (ACTUAL) 2007-09-28	Results First Posted 2015-12-17	Last Verified 2017-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Gemcitabine And Oxaliplatin A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma	DRUG: gemcitabine hydrochloride 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles DRUG: oxaliplatin 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. GENETIC: protein expression analysis GENETIC: proteomic profiling OTHER: diagnostic laboratory biomarker analysis PROCEDURE: adjuvant therapy PROCEDURE: neoadjuvant therapy PROCEDURE: therapeutic conventional surgery

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gemcitabine And Oxaliplatin

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

DRUG: gemcitabine hydrochloride

1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles

DRUG: oxaliplatin

80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.

GENETIC: protein expression analysis

GENETIC: proteomic profiling

OTHER: diagnostic laboratory biomarker analysis

PROCEDURE: adjuvant therapy

PROCEDURE: neoadjuvant therapy

PROCEDURE: therapeutic conventional surgery

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival at 18 Months	Percentage of participants that were alive or survived at 18 months after randomization	18 months

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival (Follow-Up Time)		From Baseline until 2 Years and Follow-Up, up to 120 months
Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy		Baseline and 2 years
RECIST Radiologic Response to Neoadjuvant Therapy	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR	2 years
Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy		Baseline and 2 years
Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy	Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy	Baseline and 2 years
Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy	Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy	Baseline and 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed pancreatic adenocarcinoma

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

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 anticoagulation)
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 enrollment

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 therapy
Concurrent low molecular weight heparin or warfarin, where medically indicated, allowed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Eileen O'Reilly, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

O'Reilly EM, Perelshteyn A, Jarnagin WR, Schattner M, Gerdes H, Capanu M, Tang LH, LaValle J, Winston C, DeMatteo RP, D'Angelica M, Kurtz RC, Abou-Alfa GK, Klimstra DS, Lowery MA, Brennan MF, Coit DG, Reidy DL, Kingham TP, Allen PJ. A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma. Ann Surg. 2014 Jul;260(1):142-8. doi: 10.1097/SLA.0000000000000251.

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