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Perioperative Therapy for Resectable Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00609336
First Posted: February 7, 2008
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrew Coveler, University of Washington
February 6, 2008
February 7, 2008
March 21, 2017
July 13, 2017
July 13, 2017
January 2008
November 2014   (Final data collection date for primary outcome measure)
Median Overall Survival of Patients With Adenocarcinoma of the Pancreas [ Time Frame: 5 years ]
Time at which Kaplan-Meier estimate of overall survival drops below 50%
Median overall survival
Complete list of historical versions of study NCT00609336 on ClinicalTrials.gov Archive Site
  • Percent of Patients Surviving at 5 Years [ Time Frame: Up to 5 years ]
    Kaplan-Meier estimate of overall survival at 5 years
  • Median Recurrence Free Survival Following Pancreaticoduodenectomy [ Time Frame: From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years ]
    The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence.
  • Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy [ Time Frame: Up to 7 years ]
    Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
  • Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy [ Time Frame: Up to 7 years ]
    The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM). Cancer 2012;118:1382-90
  • CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy [ Time Frame: Up to 26 weeks after surgery ]
    Biochemical response is a decrease of >= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline.
  • Surgical Completion Rate and Complication Rate [ Time Frame: Up to 6 weeks following the completion of chemoradiotherapy ]
  • Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: Up to 26 weeks after surgery (the end of adjuvant chemotherapy) ]
  • Percent of Patients Surviving at Annual Intervals [ Time Frame: 5 years ]
  • 1- and 2-year survival rate
  • Median recurrence-free survival following pancreaticoduodenectomy
  • Clinical response rate to induction chemotherapy and neoadjuvant chemoradiotherapy
  • Pathologic response rate to induction chemotherapy and neoadjuvant chemoradiotherapy
  • Biochemical response rate (CA 19-9 tumor marker) to induction chemotherapy and neoadjuvant chemoradiotherapy
  • Surgical completion rate and complication rate following induction chemotherapy and neoadjuvant chemoradiotherapy
  • Toxicity
Not Provided
Not Provided
 
Perioperative Therapy for Resectable Pancreatic Cancer
A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma
This phase II trial studies how well giving combination chemotherapy together with intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with localized pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with intensity-modulated radiation therapy 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.

PRIMARY OBJECTIVES:

I. To estimate the median overall survival of patients with adenocarcinoma of the pancreas treated with induction chemotherapy, neoadjuvant chemoradiotherapy, surgical resection and adjuvant chemotherapy.

SECONDARY OBJECTIVES:

I. To determine the percent of patients surviving at annual intervals through five years.

II. To determine the median recurrence free survival following pancreaticoduodenectomy.

III. To determine the clinical response rate to neoadjuvant chemotherapy and chemoradiotherapy.

IV. To determine the pathologic response rate to neoadjuvant chemotherapy and chemoradiotherapy.

V. To determine the cancer antigen (CA) 19-9 tumor marker response rate to neoadjuvant chemotherapy and chemoradiotherapy.

VI. To determine the surgical completion rate and complication rate following neoadjuvant chemotherapy and chemoradiotherapy.

VII. To determine the frequency and severity of toxicities associated with this treatment regimen.

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV) over 75 minutes and docetaxel IV over 30 or 60 minutes on days 4 and 11. Patients also receive capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

NEOADJUVANT CHEMORADIOTHERAPY: Beginning no more than 14 days after completion of induction chemotherapy, patients receive capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Patients also undergo IMRT once daily on days 1-5 and 8-13.

SURGICAL RESECTION: Approximately 2-6 weeks after completion of neoadjuvant chemoradiotherapy, patients undergo pancreaticoduodenectomy.

ADJUVANT CHEMOTHERAPY: Beginning 4-10 weeks after surgery, patients receive gemcitabine hydrochloride IV over 30 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. Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.

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

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adenocarcinoma of the Pancreas
  • Stage IA Pancreatic Cancer
  • Stage IB Pancreatic Cancer
  • Stage IIA Pancreatic Cancer
  • Stage IIB Pancreatic Cancer
  • Drug: gemcitabine hydrochloride
    Given IV
    Other Names:
    • dFdC
    • difluorodeoxycytidine hydrochloride
    • gemcitabine
    • Gemzar
  • Drug: docetaxel
    Given IV
    Other Names:
    • RP 56976
    • Taxotere
    • TXT
  • Drug: capecitabine
    Given PO
    Other Names:
    • CAPE
    • Ro 09-1978/000
    • Xeloda
  • Radiation: intensity-modulated radiation therapy
    Undergo IMRT
    Other Name: IMRT
  • Drug: oxaliplatin
    Given IV
    Other Names:
    • 1-OHP
    • Dacotin
    • Dacplat
    • Eloxatin
    • L-OHP
  • Procedure: pancreatic surgical procedure
    Undergo pancreaticoduodenectomy
    Other Name: pancreatic surgery
  • Procedure: therapeutic conventional surgery
    Undergo therapeutic conventional surgery
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
See Detailed Description
Interventions:
  • Drug: gemcitabine hydrochloride
  • Drug: docetaxel
  • Drug: capecitabine
  • Radiation: intensity-modulated radiation therapy
  • Drug: oxaliplatin
  • Procedure: pancreatic surgical procedure
  • Procedure: therapeutic conventional surgery
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2016
November 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed diagnosis of localized, resectable or borderline resectable, pancreatic adenocarcinoma T1-T3, N0-N1, M0; stage is determined by helical multi-phase computed tomography (CT) and/or endoscopic ultrasound according to published guidelines; resectability is determined by the treating surgeon and published guidelines (National Comprehensive Cancer Network)
  • Resectable Disease- Head/Body/Tail of pancreas:

    • No distant metastases
    • Clear fat plane around celiac and superior mesenteric arteries (SMA)
    • Patent superior mesenteric vein (SMV) and portal vein (PV)
  • Borderline Resectable Disease -Head/Body of pancreas:

    • Tumor abutment on SMA
    • SMV/portal vein impingement or occlusion if involving only a short segment, with open vein both proximally and distally (if proximal vein is occluded up to the portal vein branches then disease is unresectable)
    • Colon or mesocolon invasion
    • Gastroduodenal artery (GDA) encasement up to origin at hepatic artery
  • Tail of pancreas:

    • Adrenal, colon or mesocolon, or kidney invasion
    • Preoperative evidence of biopsy-positive peripancreatic lymph node
  • No prior therapy for pancreatic cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Leucocytes >= 3,000/uL
  • Absolute Neutrophil Count >= 1,500/uL
  • Platelets >= 100,000/uL
  • Total Bilirubin:

    • If within normal limits (WNL) to =< 2.0, the subject is eligible
    • If > 2.0 - < 6.0, subject is eligible IF they have a biliary stent and total bilirubin is decreasing
    • If >= 6.0, subject is not eligible
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvic transaminase [SGPT]) =< 2.5 X institutional upper limit of normal or =< 1.5 X upper limit of normal (ULN) if alkaline phosphatase (Alk Phos) > 2.5 X ULN or if the subject has a biliary stent and the liver function tests (LFTs) are decreasing the subject is eligible
  • Creatinine clearance >= 30%
  • Negative pregnancy test for women of childbearing potential; women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to swallow and retain oral medication
  • Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents
  • Histology other than adenocarcinoma
  • Patients with permanently unresectable pancreatic adenocarcinoma as determined by the treating physician and published guidelines (National Comprehensive Cancer Network)
  • Unresectable disease
  • Head of pancreas:

    • Distant metastases (includes celiac and/or para-aortic)
    • SMA, celiac encasement
    • SMV/portal occlusion
    • Aortic, inferior vena cava (IVC) invasion or encasement
    • Invasion of SMV below transverse mesocolon
  • Body of pancreas:

    • Distant metastases (includes celiac and/or para-aortic); at the discretion of the treating surgeon, body and tail lesions that have positive celiac and/or para-aortic nodes in close vicinity to the primary may be borderline rather than unresectable
    • SMA, celiac, hepatic encasement
    • SMV/portal extended occlusion
    • Aortic invasion
  • Tail of pancreas:

    • Distant metastases (includes celiac and/or para-aortic)
    • SMA, celiac encasement
    • Rib, vertebral invasion
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, docetaxel, capecitabine, oxaliplatin or other agents used in the study
  • Patients who have received prior chemotherapy or radiotherapy for the diagnosis of pancreatic cancer
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Inability to comply with study and/or follow-up procedures
  • Pregnancy or lactation
  • Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00609336
6511
NCI-2010-00553 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6511 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Andrew Coveler, University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Andrew Coveler Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP