Radiotherapy Combined With Oxaliplatin and Fluorouracil Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Stage III Pancreatic Cancer

Stage II Pancreatic Cancer

Adenocarcinoma of the Pancreas

Treatments

Drug: oxaliplatin

Drug: fluorouracil

Drug: gemcitabine hydrochloride

Radiation: radiation therapy

Study type

Interventional

Funder types

NIH

Identifiers

NCT00096070

NCCTG-N0349

NCI-2012-01816

U10CA025224 (U.S. NIH Grant/Contract)

CDR0000391191

N0349

Details and patient eligibility

About

This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced, unresectable pancreatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Oxaliplatin may also make the tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy may kill more tumor cells.

Full description

PRIMARY OBJECTIVES:

I. Determine the 1-year survival rate in patients with locally advanced, unresectable adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy, oxaliplatin, and fluorouracil followed by gemcitabine.

SECONDARY OBJECTIVES:

I. Determine overall survival, time to disease progression, and confirmed response rate in patients treated with this regimen.

II. Determine toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Unresectable disease, including subtotal resection and gross residual disease
- Locally advanced disease
No cystadenocarcinoma of the pancreas
No pancreatic tumors of neuroendocrine origin
No microscopic residual disease as only evidence of pancreatic cancer
All disease must be encompassable within standard radiotherapy fields for pancreatic cancer
No distant metastases (liver or lung metastases or peritoneal spread)
- No evidence of metastatic disease outside the planned radiotherapy field
Performance status - ECOG 0-1
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9.0 g/dL
Bilirubin ≤ 2 times upper limit of normal (ULN)
AST ≤ 3 times ULN
Creatinine ≤ 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to maintain adequate oral nutrition
No significant infection
No significant nausea or vomiting
No other medical condition that would preclude study participation
No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score < 7)
No known allergy to platinum compounds
No prior biologic therapy
No concurrent biologic therapy
No concurrent immunotherapy
No prior chemotherapy
No other concurrent chemotherapy
No prior radiotherapy that would overlap planned radiotherapy fields
No other concurrent radiotherapy
See Disease Characteristics
At least 21 days since prior laparotomy