A Phase I(Limited)/Phase II Study of Oxaliplatin (OXAL) and Gemcitabine (GEMZAR) in Patients With Metastatic Pancreatic Carcinoma
18 Years
N/A
Both
Pancreatic Cancer
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
months.
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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Steven R. Alberts, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000067431
NCT ID:
NCT00004190
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
Name | Location |
|---|---|
| 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 |
