Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer

Ohio State University Comprehensive Cancer Center

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and paclitaxel in treating patients who have metastatic or unresectable cancer.

OBJECTIVES: * Determine the maximum tolerated dose of oxaliplatin and paclitaxel in patients with metastatic or unresectable cancer. * Determine the qualitative and quantitative toxicities of this regimen in these patients. * Determine the therapeutic response to this regimen in these patients. * Determine the relationship between the pharmacokinetics of this regimen and toxicity and response in these patients. * Determine the effects of oxaliplatin on peripheral blood cells and correlate this to pharmacokinetics, toxicity, and response in these patients. OUTLINE: This is a dose escalation study. Patients receive oxaliplatin IV over 2 hours followed by paclitaxel IV over 1 hour weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oxaliplatin and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12-18 months.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

oxaliplatinDRUG

paclitaxelDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically proven metastatic or unresectable malignancy for which standard curative or palliative measures do not exist or are no longer effective * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 * Karnofsky 50-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3000/mm\^3 * Absolute neutrophil count at least 1500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * SGOT/SGPT no greater than 2.5 times upper limit of normal 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 neuropathy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No allergy to platinum compounds or antiemetics * No uncontrolled concurrent illness * No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No more than 2 prior chemotherapy regimens * No prior oxaliplatin or paclitaxel * At least 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of bone marrow Surgery: * Not specified Other: * No other concurrent investigational agents * No concurrent antiretroviral therapy for HIV (HAART)

Locations (1)

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Data from ClinicalTrials.gov

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