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

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ClinicalTrials.gov Identifier: NCT00536874
Recruitment Status : Completed
First Posted : September 28, 2007
Results First Posted : December 17, 2015
Last Update Posted : March 16, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
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 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin in Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
Study Start Date : October 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival at 18 Months [ Time Frame: 18 months ]
    Percentage of participants that were alive or survived at 18 months after randomization


Secondary Outcome Measures :
  1. Overall Survival (Follow-Up Time) [ Time Frame: From Baseline until 2 Years and Follow-Up, up to 120 months ]
  2. Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy [ Time Frame: Baseline and 2 years ]
  3. RECIST Radiologic Response to Neoadjuvant Therapy [ Time Frame: 2 years ]
    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

  4. Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy [ Time Frame: Baseline and 2 years ]
  5. Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy [ Time Frame: Baseline and 2 years ]
    Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy

  6. Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy [ Time Frame: Baseline and 2 years ]
    Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536874


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065-0009
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Eileen O'Reilly, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Peter J. Allen, MD Memorial Sloan Kettering Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00536874    
Other Study ID Numbers: 07-113
MSKCC-07113
First Posted: September 28, 2007    Key Record Dates
Results First Posted: December 17, 2015
Last Update Posted: March 16, 2017
Last Verified: February 2017
Keywords provided by Memorial Sloan Kettering Cancer Center:
adenocarcinoma of the pancreas
stage IA pancreatic cancer
stage IB pancreatic cancer
 stage IIA pancreatic cancer
stage IIB pancreatic cancer
stage III pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Oxaliplatin
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs