AzTrials
AzTrials

Pancreatic CancerPhase 2NCT00536874

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

A Phase 2 study testing gemcitabine hydrochloride, oxaliplatin and protein expression analysis in people with Pancreatic Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
gemcitabine hydrochloride, oxaliplatin and protein expression analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
Oct 2007to Feb 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065-0009

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
gemcitabine hydrochloride, oxaliplatin, protein expression analysis, proteomic profiling, diagnostic laboratory biomarker analysis
Keywords
adenocarcinoma of the pancreas, stage IA pancreatic cancer, stage IB pancreatic cancer, stage IIA pancreatic cancer, stage IIB pancreatic cancer, stage III pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00536874
Study groupRoleWhat they receive
Gemcitabine And OxaliplatinExperimentalA Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival at 18 Months

    Percentage of participants that were alive or survived at 18 months after randomization

    Measured: 18 months

Secondary outcomes (6)

  1. Overall Survival (Follow-Up Time)

    Measured: From Baseline until 2 Years and Follow-Up, up to 120 months

  2. Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy

    Measured: Baseline and 2 years

  3. 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

    Measured: 2 years

  4. Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy

    Measured: Baseline and 2 years

  5. Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy

    Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy

    Measured: Baseline and 2 years

  6. 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

    Measured: Baseline and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionSep 2012
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00536874
Sponsor's protocol ID
07-113
Other IDs
MSKCC-07113
Status last verified
Feb 2017
First submitted
27 Sep 2007
Last updated
16 Mar 2017

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.

    PubMed 24901360

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride, oxaliplatin and protein expression analysis in people with Pancreatic Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival at 18 Months (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00536874, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.

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