Search / Trial NCT00001835

Oxaliplatin in Cancer Patients With Impaired Kidney Function

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

Trial Information

Current as of December 08, 2024

Completed

Keywords

Renal Dysfunction Pharmacokinetics Platinum Analogues Renal Cancer Kidney Cancer

ClinConnect Summary

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 strati...

Gender

ALL

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

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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