Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer



Status:Completed
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 1999
End Date:June 2003

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A Phase I(Limited)/Phase II Study of Oxaliplatin (OXAL) and Gemcitabine (GEMZAR) in Patients With Metastatic Pancreatic Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and oxaliplatin
in treating patients who have refractory locally advanced or metastatic pancreatic cancer.

OBJECTIVES: I. Determine the safety and tolerability of gemcitabine plus oxaliplatin in
patients with refractory metastatic or locally advanced pancreatic cancer (phase I portion
of the study closed as of 7/5/00). II. Determine the objective tumor response rate to this
combination regimen in this patient population.

OUTLINE: This is a dose escalation and efficacy study. Patients receive gemcitabine IV over
30 minutes on days 1 and 8 immediately followed by oxaliplatin IV over 2 hours on day 1.
Treatment repeats every 3 weeks. Patients achieving stable disease, partial response, or
regressive disease continue with therapy. Patients achieving complete response for two
consecutive evaluations receive an additional 2 courses of therapy. Phase I (closed as of
7/5/00): Cohorts of 3-6 patients receive escalating doses of gemcitabine and oxaliplatin
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 patients experience dose limiting toxicity. Phase II:
Patients receive the MTD of gemcitabine and oxaliplatin as in phase I. Patients are followed
every 3 months for 1 year, and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 32-52 patients (12 patients to phase I (phase I closed as of
7/5/00) and 20-40 to phase II) will be accrued for this study within approximately 11-28
months.

DISEASE CHARACTERISTICS: Histologically confirmed ductal or undifferentiated primary
pancreatic cancer for which no standard curative therapy exists Progressive locally
advanced disease after combined chemotherapy and radiotherapy OR Not a candidate for
combined therapy OR Metastatic disease No islet cell, acinar cell, or cystadenocarcinomas
Measurable or evaluable disease No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100%
Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater
than upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no
greater than ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic
congestive heart failure No unstable angina No cardiac arrhythmia Other: No other
uncontrolled illness No active infection No allergy to platinum compounds, gemcitabine, or
antiemetics No other malignancy within the past 5 years except basal cell skin cancer or
carcinoma in situ of the cervix No evidence of neuropathy except preexisting grade I or II
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
or immunotherapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy for
metastatic disease At least 6 months since prior adjuvant chemotherapy, including
cisplatin or gemcitabine, for radiosensitization in locally advanced disease No prior
cisplatin or gemcitabine for locally advanced disease No other concurrent chemotherapy
Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to 25% or more of
bone marrow No concurrent radiotherapy Surgery: Not specified Other: No other concurrent
investigational agents
We found this trial at
19
sites
Saint Cloud, Minnesota 56303
571
mi
from
Saint Cloud, MN
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Ann Arbor, Michigan 48106
805
mi
from
Ann Arbor, MI
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Bismarck, North Dakota 58501
643
mi
from
Bismarck, ND
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Cedar Rapids, Iowa 52403
440
mi
from
Cedar Rapids, IA
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Danville, Pennsylvania 17822
1151
mi
from
Danville, PA
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
346
mi
from
Des Moines, IA
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
689
mi
from
Duluth, MN
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Fargo, North Dakota 58122
633
mi
from
Fargo, ND
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259
mi
from
Omaha, NE
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485
mi
from
Peoria, IL
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
520
mi
from
Rapid City, SD
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Regina, Saskatchewan
938
mi
from
Regina,
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
515
mi
from
Rochester, MN
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Scottsdale, Arizona 85259
834
mi
from
Scottsdale, AZ
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Sioux City, Iowa 51101
336
mi
from
Sioux City, IA
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Sioux Falls, South Dakota 57104
405
mi
from
Sioux Falls, SD
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799
mi
from
Toledo, OH
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509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
541
mi
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Urbana, IL
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Wichita, Kansas 67214
27
mi
from
Wichita, KS
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