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A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma


OBJECTIVES:

- Compare survival of patients with locally advanced or metastatic pancreatic cancer
treated with prolonged infusion gemcitabine with vs without oxaliplatin vs standard
infusion gemcitabine.

- Compare the toxicity of these regimens in these patients.

- Compare the objective response in patients treated with these regimens.

- Compare the patterns of failure and progression-free survival of patients treated with
these regimens.

- Compare the reported frequency of deep vein thrombosis and pulmonary embolism among
patients treated with these regimens.

- Compare the changes in quality of life, including improved symptom control and/or
additional side effects of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance
status (0 or 1 vs 2) and disease stage (locally advanced vs metastatic). Patients are
randomized to 1 of 3 treatment arms.

- Arm I (standard treatment): Patients receive gemcitabine IV over 30 minutes once weekly
for 7 weeks followed by 1 week of rest for course 1 only. In all subsequent courses,
patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, with courses
repeating every 4 weeks in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Courses
repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

- Arm III: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV
over 120 minutes on day 2. Courses repeat every 2 weeks in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed at baseline and then at 8 and 16 weeks.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 789 patients (263 per treatment arm) will be accrued for this
study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed locally advanced or metastatic pancreatic
adenocarcinoma or poorly differentiated carcinoma

- Ineligible for curative resection

- Measurable and/or nonmeasurable disease

- Must have evidence of disease outside prior radiation fields OR radiologically
confirmed progression of disease within the radiation fields after completion of
radiotherapy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC ≥ 3,500/mm^3 OR

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 125,000/mm^3

Hepatic

- Bilirubin < 2.0 mg/dL

- AST < 3 times upper limit of normal (ULN)

Renal

- Creatinine ≤ 1.5 times ULN

Cardiovascular

- No uncontrolled cardiac disease

Other

- Not pregnant or nursing

- Negative pregnancy test

- Negative vaginal ultrasound for patients with an elevated beta human chorionic
gonadotropin level

- Fertile patients must use effective nonhormonal contraception

- No other malignancies within the past 5 years except nonmetastatic, nonmelanoma skin
cancer, carcinoma in situ of the cervix, or cancer cured by surgery or small field
radiotherapy

- No active or uncontrolled infection

- No other active illness that would preclude study participation

- No symptomatic sensory peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for metastatic disease

- No prior (including adjuvant) gemcitabine or oxaliplatin

- Prior adjuvant chemotherapy allowed provided there was more than 6 months between the
last dose of adjuvant chemotherapy and recurrence of pancreatic cancer

- Prior chemotherapy as a radiosensitizing agent allowed* NOTE: *To the primary site

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy to the primary tumor site and recovered

- No prior radiotherapy to more than 25% of the functional bone marrow

Surgery

- See Disease Characteristics

- Prior surgical resection allowed

Other

- No concurrent participation in supportive care trials

- Concurrent enrollment on protocol ECOG-E1Y03 allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Elizabeth A. Poplin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000287015

NCT ID:

NCT00058149

Start Date:

March 2003

Completion Date:

Related Keywords:

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

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Cancer Center at Tufts - New England Medical CenterBoston, Massachusetts  02111
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Abramson Cancer Center at the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - OklahomaTulsa, Oklahoma  74136
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Comprehensive Cancer InstituteHuntsville, Alabama  35801
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
Medical Center of Aurora - South CampusAurora, Colorado  80012-0000
Rocky Mountain Cancer Centers - Denver RoseDenver, Colorado  80220
Rocky Mountain Cancer Centers - ThorntonThornton, Colorado  80229
La Grange Oncology AssociatesLa Grange, Illinois  60525