Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborators:	National Cancer Institute (NCI) Radiation Therapy Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00057876

Purpose

RATIONALE: Drugs used in chemotherapy work in 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. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: gemcitabine hydrochloride Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Overall survival at 13, 20, 26, and 36 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response rate [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Toxicity as measured by NCI CTC v2.0 [ Designated as safety issue: Yes ]
Quality of life as measured by Functional Assessment of Cancer Treatment-Hepatobiliary Symptom Index at baseline, 6, 15, and 16 weeks, and at 9 months [ Designated as safety issue: No ]

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

Detailed Description:

OBJECTIVES:

Compare the progression-free and overall survival of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy.
Compare the objective response rate in patients treated with these regimens.
Compare the toxicity of these regimens in these patients.
Compare the quality of life (QOL) of patients treated with these regimens.
Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1) and weight loss within the past 6 months (less than 10% vs 10% or more). Patients are randomized to 1 of 2 treatment arms.

Arm I (Gemcitabine alone):

Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest.
Consolidation: After the 1 week of rest, patients receive gemcitabine IV once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Arm II (Gemcitabine with radiotherapy):

Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks beginning on day 1. Patients also undergo concurrent radiotherapy 5 days a week for 5.5 weeks beginning on day 1.
Consolidation: Approximately 4 weeks after completion of radiotherapy, patients receive gemcitabine IV over 30-60 minutes once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, week 6, week 15 (for arm II), week 16 (for arm I), and 9 months.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year. Patients who receive treatment beyond 3 years are followed for survival.

PROJECTED ACCRUAL: Approximately 332 patients will be accrued for this study within 2 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced or regional (encompassable within the same radiotherapy portals) disease
- No M1 disease
- Adenosquamous cancers are allowed
The following cellular types are not allowed:
- Small cell
- Mucinous cystadenocarcinoma
- Islet cell
- Papillary cystic neoplasms
Unresectable disease, defined as a tumor causing superior mesenteric vein or portal vein occlusion OR superior mesenteric artery or hepatic artery encasement
Must not be a candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)
Measurable and/or nonmeasurable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

At least 12 weeks

Hematopoietic

Absolute granulocyte count at least 2,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis)
AST less than 5 times upper limit of normal (ULN)
Albumin greater than 2.5 g/dL

Renal

Creatinine no greater than 1.5 times ULN

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Willing and able to attend follow-up visits
Concurrent enrollment on protocol ECOG-E1Y03 allowed
No active infection within the past 4 weeks
No other malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7)
No history of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma)
No signs or symptoms of peptic or duodenal ulcer disease
No concurrent serious systemic disorders that are incompatible with study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy for pancreatic cancer

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy
No concurrent intensity modulated radiotherapy

Surgery

See Disease Characteristics

Other

More than 4 weeks since prior investigational agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057876

Show 229 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Investigators

Study Chair:	Patrick J. Loehrer, MD	Indiana University Melvin and Bren Simon Cancer Center
Study Chair:	Christopher H. Crane, MD	M.D. Anderson 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:

Loehrer PJ, Powell ME, Cardenes HR, et al.: A randomized phase III study of gemcitabine in combination with radiation therapy versus gemcitabine alone in patients with localized, unresectable pancreatic cancer: E4201. [Abstract] J Clin Oncol 26 (Suppl 15): A-4506, 2008.

Study ID Numbers:	CDR0000278947, ECOG-E4201, RTOG-ECOG-E4201
Study First Received:	April 7, 2003
Last Updated:	May 29, 2009
ClinicalTrials.gov Identifier:	NCT00057876 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009