Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer
This trial is active, not recruiting.
|Condition||unspecified adult solid tumor, protocol specific|
|Sponsor||Ohio State University Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||October 1999|
|Trial identifier||NCT00004173, CDR0000067419, NCI-T99-0017, OSU-99H0284|
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.
Male or female participants at least 18 years old.
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)
|Official title||A Phase I Study of Oxaliplatin in Combination With Paclitaxel|
|Description||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.|
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