Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00049348

Purpose

RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens combining chemotherapy with radiation therapy in treating patients who are undergoing surgery for locally advanced pancreatic cancer.

Condition	Intervention	Phase
Pancreatic Cancer	Biological: epoetin alfa Biological: filgrastim Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Phase II Study Of Gemcitabine Plus Radiotherapy Vs. Gemcitabine, 5-Fluorouracil And Cisplatin Followed By Radiotherapy And 5-Fluoraracil For Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer Surgery

Drug Information available for: Fluorouracil Erythropoietin Cisplatin Gemcitabine Epoetin alfa Filgrastim Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Percentage of margin-free resections produced by each program [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy as measured by CT scan response [ Designated as safety issue: No ]
Post-treatment fibrosis in the resected specimens [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Duration of objective response [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Effect of therapy and recurrence on CA19-9 values [ Designated as safety issue: No ]

Study Start Date:	May 2003
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Compare the percentage of margin-free resections in patients with locally advanced, potentially resectable adenocarcinoma of the pancreas treated with gemcitabine and radiotherapy vs gemcitabine, fluorouracil, and cisplatin followed by radiotherapy and fluorouracil.
Compare the efficacy of these regimens, as measured by CT scan response, in these patients.
Compare the posttreatment fibrosis in resected specimens of patients treated with these regimens.
Compare the toxicity of these regimens in these patients.
Compare the duration of objective response in patients treated with these regimens.
Compare the disease-free and overall survival of patients treated with these regimens.
Compare the effect of these regimens and disease recurrence on CA 19-9 values in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to superior mesenteric vein (SMV)/portal vein (PV) occlusion (yes vs no), SMV/PV/superior mesenteric artery/hepatic artery abutment or narrowing (yes vs no), prior exploration (yes vs no), and whether deemed to require preoperative therapy due to other factors (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients receive gemcitabine IV over 50 minutes once weekly for 6 weeks during radiotherapy. Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy.

Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 5, 29, and 33; cisplatin IV over 60 minutes on days 1-5 and 29-33; and fluorouracil IV continuously on days 1-4 and 29-32. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily on days 6-15 and 34-43 and epoetin alfa SC weekly on weeks 1-9. After completion of chemotherapy, patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients receive fluorouracil IV continuously daily during radiotherapy. Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy.

Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 3 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 2 years.

PROJECTED ACCRUAL: A total of 80-160 patients (40-80 per treatment arm) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the pancreas
- No adenosquamous cancers or adenocarcinoma associated with cystic mucinous neoplasms
- Locally advanced disease that is potentially resectable, previously explored and considered unresectable, or deemed to require preoperative treatment for other reasons
- Primary cancer in the head, body, or tail of pancreas
Measurable disease
No 360 degree encirclement of the superior mesenteric artery, hepatic artery, or celiac axis
No metastases by CT scan and laparoscopy (if prior surgery, only CT scan required)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count greater than 2,000/mm^3
Platelet count greater than 100,000/mm^3

Hepatic

Bilirubin less than 2 mg/dL (unless secondary to bile duct blockage by tumor)
Biliary obstruction by tumor requires biliary stent at least 9 French or biliary bypass before therapy

Renal

Creatinine less than 1.7 mg/dL OR
Creatinine clearance greater than 60 mL/min

Other

No other malignancy within the past 3 years except nonmelanoma skin cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy for this disease

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy to pancreas

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049348

Show 137 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

John Parker Hoffman, MD

Fox Chase Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Landry JC, Catalano P, Hoffman J, et al.: ECOG 1200: a randomized phase II trial of gemcitabine plus radiotherapy vs gemcitabine, 5-fluorouracil and cisplatin followed by radiotherapy and 5-fluorouracil in patients with locally advanced, potentially resectable pancreatic adenocarcinoma. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2111, S272, 2006.

Study ID Numbers:	CDR0000258056, ECOG-E1200
Study First Received:	November 12, 2002
Last Updated:	May 29, 2009
ClinicalTrials.gov Identifier:	NCT00049348 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer

Additional relevant MeSH terms:

Epoetin Alfa
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Hematologic Agents
Neoplasms by Site
Cisplatin
Therapeutic Uses
Gemcitabine
Endocrine Gland Neoplasms

Digestive System Neoplasms
Neoplasms by Histologic Type
Hematinics
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Fluorouracil
Pancreatic Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on November 09, 2009