A Phase I Study of Oxaliplatin in Combination With Paclitaxel
oxaliplatin
+ paclitaxel
Treatment Study
Summary
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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)
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Arthur G. James Cancer Hospital - Ohio State University
Columbus, United StatesOpen Arthur G. James Cancer Hospital - Ohio State University in Google Maps