Perioperative Therapy for Resectable Pancreatic Cancer

NCT00609336 | Completed Phase 2 Results

• 3 other identifiers: 6511NCI-2010-00553P30CA015704
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenocarcinoma of the Pancreas; Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Median Overall Survival of Patients With Adenocarcinoma of the Pancreas

  Time at which Kaplan-Meier estimate of overall survival drops below 50%

  5 years

Secondary Outcomes (8)

• Percent of Patients Surviving at 5 Years

  Up to 5 years

• Median Recurrence Free Survival Following Pancreaticoduodenectomy

  From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years

• Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy

  Up to 7 years

• Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy

  Up to 7 years

• CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy

  Up to 26 weeks after surgery

Study Arms (1)

Treatment (chemotherapy, radiation, pancreaticoduodenectomy)

EXPERIMENTAL

See Detailed Description

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

Interventions

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Treatment (chemotherapy, radiation, pancreaticoduodenectomy)

docetaxel DRUG

Given IV

Also known as: RP 56976, Taxotere, TXT

Treatment (chemotherapy, radiation, pancreaticoduodenectomy)

capecitabine DRUG

Given PO

Also known as: CAPE, Ro 09-1978/000, Xeloda

Treatment (chemotherapy, radiation, pancreaticoduodenectomy)

intensity-modulated radiation therapy RADIATION

Undergo IMRT

Also known as: IMRT

Treatment (chemotherapy, radiation, pancreaticoduodenectomy)

oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Treatment (chemotherapy, radiation, pancreaticoduodenectomy)

pancreatic surgical procedure PROCEDURE

Undergo pancreaticoduodenectomy

Also known as: pancreatic surgery

Treatment (chemotherapy, radiation, pancreaticoduodenectomy)

therapeutic conventional surgery PROCEDURE

Undergo therapeutic conventional surgery

Treatment (chemotherapy, radiation, pancreaticoduodenectomy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (chemotherapy, radiation, pancreaticoduodenectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Docetaxel; Capecitabine; Radiotherapy, Intensity-Modulated; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Coordination Complexes

Results Point of Contact

• Title: Andrew Coveler, MD
• Organization: University of Washington

acoveler@uw.edu

206-288-7509

Study Officials

• Andrew Coveler

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 7, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2016
• Last Updated: July 13, 2017
• Results First Posted: July 13, 2017

Record last verified: 2017-06

Locations

US (1)