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A Phase II Trial of External Irradiation (50.4 GY) and Weekly Paclitaxel (Taxol) for Non-Metastatic, Unresectable Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Phase II Trial of External Irradiation (50.4 GY) and Weekly Paclitaxel (Taxol) for Non-Metastatic, Unresectable Pancreatic Cancer

OBJECTIVES: I. Determine the response rate of patients with nonmetastatic, unresectable
pancreatic cancer receiving external beam irradiation and weekly paclitaxel. II. Determine
the median survival after this treatment in these patients. III. Evaluate the acute and late
treatment morbidity of paclitaxel in these patients. IV. Correlate p53 status with treatment
response to this treatment in this patient population.

OUTLINE: This is a open label, multicenter study. Patients are highly recommended to undergo
laparoscopic surgical staging prior to protocol to exclude peritoneal and hepatic
metastases. Patients receive paclitaxel IV over 3 hours weekly for 6 weeks beginning on day
1 followed 1.5 hours later by external beam radiotherapy daily 5 days a week for 5.5 weeks
beginning on day 1. All patients are restaged with an abdominal CT scan 6 weeks following
completion of chemoradiotherapy. If there is marked response to treatment at this time,
curative surgery may be attempted at the discretion of the attending surgeon. Patients are
followed every 3 months for 1 year, every 4 months for the second year, every 6 months for
years 3-5, and annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued into this study over 12 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed nonmetastatic, unresectable pancreatic
adenocarcinoma No evidence of metastatic disease in the major viscera and no peritoneal
seeding Residual disease after resection (R-1 or -2 micro- and macroscopic residual)
eligible if measurable disease on the post operative CT or MRI scan Recurrent disease
following radical surgery is eligible All malignant disease must be encompassable within a
single irradiation field Must be a radiographically assessable disease CT with 5 mm cuts
or spiral CT

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Granulocyte count at least 1,800/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL Biliary system
stented Renal: Creatinine less than 3.0 mg/dL OR Creatinine clearance at least 40 mL/min
Other: If patients have biliary or gastroduodenal obstruction, they must have drainage
prior to starting chemoradiation Oral intake of at least 1,500 calories per day No
significant infection or other coexistent medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
paclitaxel At least 4 weeks since prior gemcitabine No other prior chemotherapy Endocrine
therapy: Not specified Radiotherapy: No prior radiotherapy to the planned field Surgery:
See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Tyvin A. Rich, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Virginia


United States: Federal Government

Study ID:




Start Date:

November 1998

Completion Date:

Related Keywords:

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



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