Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Renal Insufficiency

Antineoplastic Agents

All Drugs and Chemicals

Rubitecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of rubitecan in this patient population.

Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction

Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction

Astex Pharmaceuticals, Inc.

Neoplasms

Symptoms and General Pathology

Rare Diseases

Kidney Diseases

Neoplasm Metastasis

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplastic Processes

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Cell Carcinoma

Oxaliplatin

Oxaliplatin is an experimental anti-cancer drug that can shrink tumors such as colon cancer. However, because this drug can damage the kidneys, it is necessary to determine what doses of the drug can safely be given to patients with poor kidney function.

Patients with advanced cancer, poorly functioning kidneys, and no good standard treatment options are eligible for this study. Candidates will be screened with imaging tests, such as CT and MRI scans, to determine the size and location of the cancer and with blood and urine tests to evaluate kidney and liver function.

Study participants will receive oxaliplatin intravenously (through a vein) every 3 weeks for as long as the cancer is under control and there are no serious side effects from the drug. If significant side effects develop, the dosage will be reduced, or the drug will be stopped. Blood tests to measure blood cell counts will be done at least once a week, and CT scans, chest X-rays, and MRIs will be done about once every 6 weeks to assess the tumor's response to the treatment. Additional blood tests will be done at the beginning of the first two treatment cycles to measure the amount of oxaliplatin in the blood, and urine will be collected during the first 24 hours of drug treatment to determine how much drug is eliminated by the body in urine.

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.

Oxaliplatin in Cancer Patients With Impaired Kidney Function

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

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction	NCT00113113	Tumors	Rubitecan	18 Years -	Astex Pharmaceuticals, Inc.
Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction	NCT00113113	Tumors	Rubitecan	18 Years -	Astex Pharmaceuticals, Inc.
Oxaliplatin in Cancer Patients With Impaired Kidney Function	NCT00001835	Kidney Disease Neoplasm Neoplasm Metast...	Oxaliplatin	-	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for renal dysfunction