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Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Pancreas, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer

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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 GroupRochester, Minnesota  55905