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A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer


OBJECTIVES:

- Compare the overall survival rate of patients with metastatic pancreatic cancer treated
with gemcitabine alone vs with cisplatin vs with docetaxel vs with irinotecan.

- Compare the time to disease progression in patients treated with these regimens.

- Compare the CA 19-9 biomarker response in patients treated with these regimens.

- Correlate the CA 19-9 biomarker response with survival in patients treated with these
regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the response in patients with measurable disease treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four
treatment arms.

- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by
cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for at
least 2 courses in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15.
Treatment repeats every 28 days for at least 2 courses in the absence of disease
progression or unacceptable toxicity.

- Arm III: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over
60 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in
the absence of disease progression or unacceptable toxicity.

- Arm IV: Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over
90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in
the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 240 patients (60 per arm) will be accrued for this study
within 30 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the pancreas

- Metastatic disease by CT scan

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- CTC 0-2

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 1.5 mg/dL

- SGOT no greater than 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase less than 2.5 times ULN if SGOT greater than 1.5 times ULN

- Alkaline phosphatase any value if SGOT less than 1.5 times ULN

Renal:

- Creatinine no greater than 1.5 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study

- No other currently active malignancy (completed therapy and considered to be at less
than 30% risk of relapse) except non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy except fluorouracil (5-FU)

- At least 2 weeks since prior 5-FU

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except steroids for adrenal failure, hormonal therapy
for non-disease related conditions (e.g., insulin for diabetes), or intermittent use
of dexamethasone as an antiemetic

Radiotherapy:

- At least 2 weeks since prior radiotherapy

- No concurrent palliative radiotherapy except whole-brain irradiation for CNS disease

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

4 years post treatment

Safety Issue:

No

Principal Investigator

Matthew Kulke, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068495

NCT ID:

NCT00012220

Start Date:

January 2001

Completion Date:

April 2009

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lombardi Cancer CenterWashington, District of Columbia  20007
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Martha Jefferson HospitalCharlottesville, Virginia  22901
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Florida Hospital Cancer InstituteOrlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida  33021
Helen and Harry Gray Cancer Institute at Good Samaritan Medical CenterWest Palm Beach, Florida  33401
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Saint Anthony Medical CenterRockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
NorthEast Oncology AssociatesConcord, North Carolina  28025
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Ministry Medical Group - Northern RegionRhinelander, Wisconsin  54501
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021