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A Phase II Study Of Neo-Adjuvant Chemotherapy And Radiation In Patients With Locally Advanced Pancreatic Cancer


Phase 2
19 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

A Phase II Study Of Neo-Adjuvant Chemotherapy And Radiation In Patients With Locally Advanced Pancreatic Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor and clinical benefit response

Outcome Time Frame:

After 6 weeks of chemotherapy and then after 4 weeks of chemo-radiation.

Safety Issue:

No

Principal Investigator

Jean L. Grem, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska

Authority:

United States: Federal Government

Study ID:

035-04

NCT ID:

NCT00089024

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680