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

NCT ID: NCT00536874

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2017-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine And Oxaliplatin

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

Group Type: EXPERIMENTAL

gemcitabine hydrochloride

Intervention Type: DRUG

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

oxaliplatin

Intervention Type: DRUG

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

protein expression analysis

Intervention Type: GENETIC

proteomic profiling

Intervention Type: GENETIC

diagnostic laboratory biomarker analysis

Intervention Type: OTHER

adjuvant therapy

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

Interventions

gemcitabine hydrochloride

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

Intervention Type: DRUG

oxaliplatin

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

Intervention Type: DRUG

protein expression analysis

Intervention Type: GENETIC

proteomic profiling

Intervention Type: GENETIC

diagnostic laboratory biomarker analysis

Intervention Type: OTHER

adjuvant therapy

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eileen O'Reilly, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Peter J. Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24901360 (View on PubMed)

Other Identifiers

MSKCC-07113

Identifier Type: -

Identifier Source: secondary_id

07-113

Identifier Type: -

Identifier Source: org_study_id