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A Phase I Study of Oxaliplatin in Combination With Gemcitabine

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of Oxaliplatin in Combination With Gemcitabine

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicities of
gemcitabine in combination with oxaliplatin in patients with advanced malignancies. II.
Determine the pharmacokinetics of oxaliplatin and gemcitabine in these patients.

OUTLINE: This is a multicenter, dose escalation study of gemcitabine. Patients receive
oxaliplatin IV over 2 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
Treatment continues every 3 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination
with a fixed dose of oxaliplatin until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting

PROJECTED ACCRUAL: A total of 24-36 patients will be accrued for this study within 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable malignancy for
which standard therapy does not exist or is no longer effective No greater than 3 prior
treatment regimens No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 2 months Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil
count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal
SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR
Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart
failure No unstable angina pectoris No cardiac arrhythmia Other: No clinically significant
neuropathy Not pregnant or nursing Fertile patients must use effective contraception No
allergy to platinum compounds or antiemetics No uncontrolled active infection or other

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: See
Disease Characteristics Radiotherapy: See Disease Characteristics No prior radiotherapy to
at least 30% of bone marrow At least 4 weeks since prior radiotherapy Surgery: See Disease
Characteristics Other: No other concurrent investigational agents No other concurrent
anticancer therapy No HIV positive patients receiving antiretroviral therapy (HAART)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Stephen I. Shibata, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific



Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
University of California Davis Cancer Center Sacramento, California  95817