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A Phase I Study of Oxaliplatin in Adult Cancer Patients With Impaired Renal Function

Phase 1
Not Enrolling
Kidney Disease, Neoplasm, Neoplasm Metastasis

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Trial Information

A Phase I Study of Oxaliplatin in Adult Cancer Patients With Impaired Renal Function

Oxaliplatin is a diaminocyclohexane platinum derivative with known anticancer activity in
solid tumors. The recommended single-agent dose of Oxaliplatin in adult cancer patients
with normal renal function is 130 mg/m(2) given intravenously over 2 hours every 3 weeks.
Renal excretion is thought to be the major route of drug elimination, but precise dosing
guidelines in patients with abnormal renal function have not been determined. This phase I
and pharmacologic study of single agent Oxaliplatin is being conducted in adult cancer
patients with impaired renal function. Patients will be stratified into four groups based
upon their degree of renal impairment as assessed by a 24 hour creatinine clearance. Group
A will consist of 12 patients with normal renal function who will serve as pharmacologic
controls. The remaining 3 groups will start at different doses of Oxaliplatin based upon
their degree of renal dysfunction and dose escalation in these groups will proceed in a
manner in accordance with standard phase I trials with 3 patients per dose level until dose
limiting toxicity is observed. Pharmacokinetic monitoring will be performed in all patients
on study. The goals of this trial are to define the toxicities and pharmacokinetics of
single agent Oxaliplatin in this patient population and to determine recommended doses of
Oxaliplatin in patient with different degrees of renal dysfunction.

Inclusion Criteria

Patients must have histologically confirmed malignancy which is metastatic or unresectable
and for which standard curative or palliative measures do not exist or are no longer

Patients with prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy
are allowed with the exception that patients cannot have had prior treatment with

Patients greater than or equal to 18 years of age.

Patients must have an ECOG performance status less than or equal to 2 (Karnofsky greater
than or equal to 60 percent) and a life expectancy of at least 3 months.

Patients must have adequate organ and marrow function which includes:

Leukocytes must be greater than or equal to 3,000/microliter.

Absolute neutrophil count must be greater than or equal to 1,500/microliter.

Platelet count must be greater than or equal to 100,000/microliter.

Total bilirubin within normal institutional limits.

AST (SGOT)/ALT(SGPT) less than or equal to 1.5 times the upper limit of normal.

Patients with no evidence of clinically significant neuropathy.

Women of child-bearing potential and men must agree to use adequate contraception.

Patients must have the ability to understand and the willingness to sign a written
informed consent document.

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the
study, or within 6 weeks of prior platinum therapy will be excluded.

Patients undergoing therapy with other investigational agents will be excluded.

Patients with known brain metastaseswill be excluded.

Patients with a history of an allergy to platinum compounds will be excluded.

Patients with uncontrolled intercurrent illness including but not limited to ongoing or
active infection, symptomatic congestive heart failure, or unstable angina pectoris, or
cardiac arrhythmia will be excluded.

Women must not be pregnant or nursing.

Patients must not be HIV-positive or receiving anti-retroviral therapy (HAART).

Patients actively receiving renal dialysis treatments while on the study will be excluded.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

September 1999

Completion Date:

December 2001

Related Keywords:

  • Kidney Disease
  • Neoplasm
  • Neoplasm Metastasis
  • Renal Dysfunction
  • Pharmacokinetics
  • Platinum Analogues
  • Renal Cancer
  • Kidney Cancer
  • Neoplasms
  • Kidney Diseases
  • Neoplasm Metastasis



National Cancer Institute (NCI) Bethesda, Maryland  20892