Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer - Full Text View

Sponsors and Collaborators:	University of Nebraska National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00089024

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients who may undergo surgery for locally advanced pancreatic cancer.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Gemcitabine hydrochloride Gemcitabine Fluorouracil Oxaliplatin Calcium gluconate Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Of Neo-Adjuvant Chemotherapy And Radiation In Patients With Locally Advanced Pancreatic Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Antitumor and clinical benefit response [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Correlation of achieved steady-state plasma levels with clinical toxicity [ Designated as safety issue: Yes ]
Importance of polymorphic variations in genomic DNA of pertinent genes on response and toxicity [ Designated as safety issue: Yes ]
Gene expression profiles of primary and metastatic pancreatic tumors before and after treatment [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	February 2004
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the antitumor and clinical benefit response to neoadjuvant chemoradiotherapy comprising gemcitabine, fluorouracil, leucovorin calcium, and oxaliplatin in patients with potentially resectable locally advanced adenocarcinoma of the pancreas.
Determine the toxic effects of this regimen in these patients.
Determine the achieved steady-state plasma levels of gemcitabine and fluorouracil in these patients and correlate these plasma levels with clinical toxicity associated with this regimen.
Determine the potential importance of polymorphic variations in genomic DNA of pertinent genes (whose protein products are targets of the antineoplastic drugs used in this study) on response to and toxicity of this regimen in these patients.
Determine the gene expression profiles of primary and metastatic pancreatic tumors before and after treatment with this regimen.

OUTLINE:

Neoadjuvant chemotherapy: Patients receive gemcitabine IV over 30 minutes and fluorouracil IV continuously over 24 hours on days 2 and 9, and leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Neoadjuvant chemoradiotherapy: Beginning on day 42, patients undergo chemoradiotherapy comprising oxaliplatin IV over 2 hours on days 42, 49, 56, 63, 70, and 77 and fluorouracil IV continuously on days 42-78 with external beam radiotherapy.
Surgery: Patients undergo surgical resection 42-56 days after completion of chemoradiotherapy.
Adjuvant chemotherapy: After post-operative recovery, patients receive 2 additional courses of gemcitabine, fluorouracil, and leucovorin calcium. If surgical resection is not possible, patients with stable or responsive disease resume gemcitabine, fluorouracil, and leucovorin calcium indefinitely in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of adenocarcinoma of the pancreas
- Locally advanced disease
Potentially resectable disease
- No early stage resectable disease
No evidence of distant metastases to the liver or peritoneal area according to imaging studies and laparoscopic staging

PATIENT CHARACTERISTICS:

Age

19 and over

Performance status

Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count ≥ 2,000/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 2.0 mg/dL (in the absence of biliary obstruction)
- If biliary obstruction is present, patients must undergo biliary decompression
  - Bilirubin ≤ 3.0 mg/dL after biliary drainage has been established

Renal

Creatinine ≤ 1.6 mg/dL

Cardiovascular

No symptomatic congestive heart failure
No unstable angina pectoris
No serious uncontrolled cardiac arrhythmia

Other

Not pregnant or nursing
No uncontrolled illness
No active or ongoing infection requiring IV antibiotics
No marked intolerance to 5-fluoropyrimidines (i.e., fluorouracil, floxuridine, capecitabine, or fluorocytosine)
No allergy to sulfonamides, aspirin, or non-steroidal anti-inflammatory drugs
No allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with study chemotherapy
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy for pancreatic cancer

Endocrine therapy

Not specified

Radiotherapy

No prior abdominal radiotherapy

Surgery

Not specified

Other

No concurrent non-steroidal anti-inflammatory medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089024

Locations

United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465

Sponsors and Collaborators

University of Nebraska

National Cancer Institute (NCI)

Investigators

Study Chair:

Jean L. Grem, MD

University of Nebraska

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000377892, UNMC-03504
Study First Received:	August 4, 2004
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00089024
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Leucovorin
Pancrelipase
Naphazoline
Calcium, Dietary
Oxymetazoline
Oxaliplatin
Digestive System Diseases

Guaifenesin
Phenylephrine
Fluorouracil
Gastrointestinal Neoplasms
Pancreatic Diseases
Phenylpropanolamine
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 14, 2009