Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer
18 Years
N/A
Both
Adenocarcinoma of the Pancreas, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer
Trial Information
Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
1-year survival rate
Outcome Description:
1-year survival will be considered "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. If more than 1 patients is lost to follow-up, we will use Kaplan-Meier estimates for the 6-month and 12-month overall survival rates. 95% confidence intervals for the true success proportion will be calculated according the approach of Duffy and Santner.
Outcome Time Frame:
At 1 year
Safety Issue:
No
Principal Investigator
George Kim
Investigator Role:
Principal Investigator
Investigator Affiliation:
North Central Cancer Treatment Group
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-01816
NCT ID:
NCT00096070
Start Date:
December 2004
Completion Date:
Related Keywords:
- Adenocarcinoma of the Pancreas
- Stage II Pancreatic Cancer
- Stage III Pancreatic Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Pancreatic Neoplasms
Name | Location |
|---|---|
| North Central Cancer Treatment Group | Rochester, Minnesota 55905 |
