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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cisplatin
gemcitabine hydrochloride
radiation therapy
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy that would overlap planned study radiotherapy fields Surgery: See Disease Characteristics At least 21 days since prior laparotomy

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • MBCCOP - Howard University Cancer Center
  • CCOP - Illinois Oncology Research Association
  • Methodist Medical Center of Illinois
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • Siouxland Hematology-Oncology
  • CCOP - Wichita
  • CCOP - Ochsner
  • CCOP - Michigan Cancer Research Consortium
  • CCOP - Duluth
  • Mayo Clinic Cancer Center
  • CentraCare Health Plaza
  • CCOP - Metro-Minnesota
  • CCOP - Missouri Valley Cancer Consortium
  • Medcenter One Health System
  • CCOP - Merit Care Hospital
  • Altru Cancer Center
  • CCOP - Toledo Community Hospital
  • CCOP - Geisinger Clinic and Medical Center
  • Allegheny General Hospital
  • Rapid City Regional Hospital
  • CCOP - Sioux Community Cancer Consortium
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • Allan Blair Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiotherapy + gemcitabine + cisplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

quality of life

Full Information

First Posted
November 9, 2001
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00026403
Brief Title
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer
Official Title
A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiotherapy + gemcitabine + cisplatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
overall survival
Time Frame
12 months
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy that would overlap planned study radiotherapy fields Surgery: See Disease Characteristics At least 21 days since prior laparotomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael G. Haddock, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
MBCCOP - Howard University Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
Siouxland Hematology-Oncology
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
CentraCare Health Plaza
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Medcenter One Health System
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501-5505
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Altru Cancer Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
CCOP - Toledo Community Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4772
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57709
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17577035
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

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

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