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

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

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

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

Inclusion Criteria

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven R. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • duct cell adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CentraCare Clinic Saint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C. Bismarck, North Dakota  58501
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical Center Danville, Pennsylvania  17822-2001
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080