Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer - Full Text View

Sponsors and Collaborators:	Royal Liverpool University Hospital National Cancer Institute of Canada Australasian Gastro-Intestinal Trials Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00058201

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective, or whether chemotherapy is more effective than observation, in treating pancreatic cancer after surgery.

PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Procedure: observation	Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Gemcitabine hydrochloride Gemcitabine Fluorouracil Calcium gluconate Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	European Study Group For Pancreatic Cancer - Trial 3

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

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity as measured by NCI CTC v2.0 [ Designated as safety issue: Yes ]
Quality of life as measured by EORTC QLQ C-30 and ESPAC-QLQ at 3, 6, and 12 months, and then annually for 5 years [ Designated as safety issue: No ]
Survival rate at 2 and 5 years [ Designated as safety issue: No ]

Estimated Enrollment:	1030
Study Start Date:	July 2001
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.	Drug: fluorouracil Given IV Drug: leucovorin calcium Given IV
Arm II: Experimental Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.	Drug: gemcitabine hydrochloride Given IV
Arm III: No Intervention Patients undergo observation.	Procedure: observation No intervention

Detailed Description:

OBJECTIVES:

Primary

Compare the efficacy of adjuvant gemcitabine vs fluorouracil and leucovorin calcium (vs observation only in patients with ampullary or other pancreatic malignancy), in terms of overall survival, in patients with completely resected pancreatic cancer.

Secondary

Compare the toxicity of these regimens in these patients.
Compare the quality of life and 5-year survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (ductal adenocarcinoma vs ampullary or other pancreatic malignancy), resection margin status, and participating country. Patients are randomized to 1 of 2 treatment arms. Randomization for patients with ampullary or other pancreatic malignancy includes an observation arm.

Arm I: Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.
Arm III (patients with ampullary or other pancreatic malignancy only): Patients undergo observation.

Treatment in arms I and II repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 3, 6, and 12 months, and then annually for 5 years.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 1,030 patients with pancreatic adenocarcinoma (515 per arms I and II) 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 ductal adenocarcinoma of the pancreas OR
Histologically confirmed diagnosis of 1 of the following types of cancer:
- Acinar cell carcinoma or cystadenocarcinoma of the pancreas
- Cancers of the periampullary region
- Cancers of the intrapancreatic part of the bile duct
- Periampullary cancers of uncertain origin
Complete macroscopic resection (R0 or R1 resection)
- Histological examination of all resection margins required
No stage IVB disease
No evidence of malignant ascites
No liver or peritoneal metastases
No evidence of spread to other distant abdominal or extra-abdominal organs
No pancreatic lymphoma

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

WHO 0-2

Life expectancy

More than 3 months

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant
Able to participate in long-term follow-up
No other prior or concurrent malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
No serious medical or psychological condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No neoadjuvant chemotherapy
No other concurrent chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

See Disease Characteristics
Recovered from prior resection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058201

Show 27 Study Locations

Sponsors and Collaborators

Royal Liverpool University Hospital

National Cancer Institute of Canada

Australasian Gastro-Intestinal Trials Group

Investigators

Study Chair:	John P. Neoptolemos, MD	Royal Liverpool University Hospital
Study Chair:	Malcolm J. Moore, MD	Princess Margaret Hospital, Canada
Investigator:	R. Padbury	Flinders Medical Centre
Investigator:	David Goldstein, MD	Institute of Oncology at Prince of Wales Hospital

More Information

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

Study ID Numbers:	CDR0000287023, RLUH-NCRI-ESPAC-3(V2), EU-20043, CAN-NCIC-PA2, AGITG-ESPAC-3
Study First Received:	April 7, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00058201
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

acinar cell adenocarcinoma of the pancreas
duct cell adenocarcinoma of the pancreas
stage I pancreatic cancer

stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Leucovorin
Pancrelipase
Calcium, Dietary
Digestive System Diseases

Fluorouracil
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009