Phase 2 N=29 Treatment

Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

Pancreatic Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00089024 ↗

Enrolled (actual)

Serious AEs

86.2%

Results posted

Oct 2019

Primary outcome: Primary: Surgical Exploration — 4; 6; 9 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: fluorouracil (Drug); gemcitabine hydrochloride (Drug); leucovorin calcium (Drug); oxaliplatin (Drug); adjuvant therapy (Procedure); conventional surgery (Procedure); neoadjuvant therapy (Procedure); radiation therapy (Radiation)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of Nebraska
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Surgical Exploration	4; 6; 9	—
PRIMARY Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment	4; 5; 11; 0; 12; 1	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Diagnosis of adenocarcinoma of the pancreas

o Locally advanced disease

Potentially resectable disease
19 years of age and over
Karnofsky 60-100%
Absolute granulocyte count ≥ 2,000/mm^3
Platelet count ≥ 100,000/mm^3
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
Creatinine ≤ 1.6 mg/dL

Exclusion Criteria

No early stage resectable disease
No concurrent non-steroidal anti-inflammatory medication
No evidence of distant metastases to the liver or peritoneal area according to imaging studies and laparoscopic staging
No symptomatic congestive heart failure
No unstable angina pectoris
No serious uncontrolled cardiac arrhythmia
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
No prior chemotherapy for pancreatic cancer
No prior abdominal radiotherapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00089024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.