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| Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005077 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating patients who have advanced cancer plus liver dysfunction.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: oxaliplatin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of Oxaliplatin in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction (Summary Last Modified 04/2000) |
| Study Start Date: | February 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 patients.
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 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Beckman Research Institute, City of Hope | |
| Los Angeles, California, United States, 91010 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033-0800 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| United States, New York | |
| Albert Einstein Comprehensive Cancer Center | |
| Bronx, New York, United States, 10461 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
| Study Chair: | James H. Doroshow, MD | Beckman Research Institute |
More Information
| Study ID Numbers: | CDR0000067684, CHNMC-PHI-26, CHNMC-IRB-99108, NCI-00-C-0172, NCI-NMOB-B00-033, PCI-99105, NCI-T99-0050 |
| Study First Received: | April 6, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005077 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific |
|
Oxaliplatin Liver Diseases Digestive System Diseases |
|
Oxaliplatin Liver Diseases Digestive System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
