Combination Chemotherapy Plus Radiation Therapy In Treating Patients With Advanced Pancreatic Cancer

Study Overview

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.

OBJECTIVES: * Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year survival, in patients with locally advanced pancreatic cancer. * Determine the toxicity of this regimen in these patients. * Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28 months.

Pancreatic Cancer

DRUG: cisplatin
DRUG: gemcitabine hydrochloride
RADIATION: radiation therapy

NCCTG-N9942
NCI-2012-02426 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trials Reporting System))
CDR0000069026 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-11-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-07-12
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-07-14
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2016-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: radiotherapy + gemcitabine + cisplatin Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of rad	DRUG: cisplatin DRUG: gemcitabine hydrochloride RADIATION: radiation therapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: radiotherapy + gemcitabine + cisplatin

Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of rad

DRUG: cisplatin

DRUG: gemcitabine hydrochloride

RADIATION: radiation therapy

Primary Outcome Measures	Measure Description	Time Frame
overall survival		12 months

Secondary Outcome Measures	Measure Description	Time Frame
quality of life		Up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed unresectable adenocarcinoma of the pancreas
No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin
Prior subtotal resection or gross residual disease

No microscopic residual disease only
No metastatic disease outside of planned study radiotherapy field

18 and over

ECOG 0-1

Not specified

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Bilirubin no greater than 2 times upper limit of normal (ULN)
AST no greater than 3 times ULN

Creatinine no greater than 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 other medical condition that would preclude study
No other malignancy within the past 5 years except non-melanoma skin cancer
No significant nausea or vomiting

No prior or concurrent biologic therapy

No prior chemotherapy
No other concurrent chemotherapy

Not specified

See Disease Characteristics
No prior radiotherapy that would overlap planned study radiotherapy fields

See Disease Characteristics
At least 21 days since prior laparotomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Michael G. Haddock, MD, Mayo Clinic

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Haddock MG, Swaminathan R, Foster NR, Hauge MD, Martenson JA, Camoriano JK, Stella PJ, Tenglin RC, Schaefer PL, Moore DF Jr, Alberts SR. Gemcitabine, cisplatin, and radiotherapy for patients with locally advanced pancreatic adenocarcinoma: results of the North Central Cancer Treatment Group Phase II Study N9942. J Clin Oncol. 2007 Jun 20;25(18):2567-72. doi: 10.1200/JCO.2006.10.2111.
Haddock MG, Swaminathan R, Alberts SR, et al.: Gemcitabine (Gem), cisplatin (Cis) and radiation therapy (RT) for patients with locally advanced pancreatic adenocarcinoma (ACA): a North Central Cancer Treatment Group (NCCTG) phase II study. [Abstract] J Clin Oncol 22 (Suppl 14): A-4121, 343s, 2004.

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Clinical Trial Record