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A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Pancreas, Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer

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Trial Information

A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma


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.


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 glutamic 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
v2.2006

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median overall survival of patients with adenocarcinoma of the pancreas

Outcome Description:

Estimated by the Kaplan Meier method.

Outcome Time Frame:

From the date of registration to date of death due to any cause, assessed up to 22 months

Safety Issue:

No

Principal Investigator

Andrew Coveler

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Institutional Review Board

Study ID:

6511

NCT ID:

NCT00609336

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Stage IA Pancreatic Cancer
  • Stage IB Pancreatic Cancer
  • Stage IIA Pancreatic Cancer
  • Stage IIB Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109