- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00609336
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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
See Detailed Description
|
Correlative studies
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Undergo IMRT
Other Names:
Given IV
Other Names:
Undergo therapeutic conventional surgery
Undergo pancreaticoduodenectomy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Overall Survival of Patients With Adenocarcinoma of the Pancreas
Time Frame: 5 years
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Time at which Kaplan-Meier estimate of overall survival drops below 50%
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5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Patients Surviving at 5 Years
Time Frame: Up to 5 years
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Kaplan-Meier estimate of overall survival at 5 years
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Up to 5 years
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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
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The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence.
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From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years
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Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy
Time Frame: Up to 7 years
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Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
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Up to 7 years
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Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy
Time Frame: Up to 7 years
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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
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Up to 7 years
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CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy
Time Frame: Up to 26 weeks after surgery
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Biochemical response is a decrease of >= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline.
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Up to 26 weeks after surgery
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Surgical Completion Rate and Complication Rate
Time Frame: Up to 6 weeks following the completion of chemoradiotherapy
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Up to 6 weeks following the completion of chemoradiotherapy
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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)
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Up to 26 weeks after surgery (the end of adjuvant chemotherapy)
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Percent of Patients Surviving at Annual Intervals
Time Frame: 5 years
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5 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew Coveler, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Adenocarcinoma
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gemcitabine
- Docetaxel
- Capecitabine
- Oxaliplatin
Other Study ID Numbers
- 6511 (Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
- P30CA015704 (U.S. NIH Grant/Contract)
- NCI-2010-00553 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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