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Phase I Study of Oxaliplatin in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction (Summary Last Modified 04/2000)

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

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Trial Information

Phase I Study of Oxaliplatin in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction (Summary Last Modified 04/2000)

OBJECTIVES: I. Determine the maximum tolerated dose of oxaliplatin in patients with advanced
malignancies and varying degrees of liver dysfunction. II. Determine the effects of hepatic
dysfunction on the plasma pharmacokinetics and pharmacodynamics of oxaliplatin in these

OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to
liver function as defined by the following: Group A: Normal liver function - Bilirubin,
SGOT, and alkaline phosphatase no greater than upper limit of normal (ULN) Group B: Mild
liver dysfunction - Bilirubin no greater than ULN; SGOT greater than ULN to 2.5 times ULN
and/or alkaline phosphatase greater than ULN to 5 times ULN Group C: Moderate liver function
- Bilirubin greater than ULN to 3.0 mg/dL and/or SGOT greater than 2.5 times ULN and/or
alkaline phosphatase greater than 5 times normal Group D: Severe liver dysfunction -
Bilirubin greater than 3.1 mg/dL and any SGOT or alkaline phosphatase Group E: Patients who
have received a liver transplant Patients receive oxaliplatin IV over 2 hours on day 1.
Treatment repeats every 3 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients in groups B, C, and D receive escalating doses of
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.

PROJECTED ACCRUAL: Approximately 72 patients will be accrued for this study within 1.5

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or unresectable malignancy
for which no curative or palliative treatment exists No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 2 months Hematopoietic: Platelet count at least 100,000/mm3 WBC at
least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3 Hepatic: Abnormal liver
function allowed 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 history of allergy to platinum
compounds or antiemetics which may be used with study No uncontrolled concurrent illness
(e.g., ongoing or active infection)

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors
during first course of study Chemotherapy: No more than 3 prior regimens of chemotherapy
At least 6 weeks since prior platinum chemotherapy At least 4 weeks since other prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more
than 30% of bone marrow Surgery: At least 10 days since placement of biliary shunt Other:
No other concurrent investigational agents No concurrent antiretroviral therapy (HAART) in
HIV positive patients

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

James H. Doroshow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

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



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