Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
OBJECTIVES:
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Determine the maximum tolerated dose of oxaliplatin and paclitaxel in patients with metastatic or unresectable cancer.
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Determine the qualitative and quantitative toxicities of this regimen in these patients.
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Determine the therapeutic response to this regimen in these patients.
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Determine the relationship between the pharmacokinetics of this regimen and toxicity and response in these patients.
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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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically proven metastatic or unresectable malignancy for which standard curative or palliative measures do not exist or are no longer effective
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No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
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ECOG 0-2
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Karnofsky 50-100%
Life expectancy:
- Not specified
Hematopoietic:
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WBC at least 3000/mm^3
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Absolute neutrophil count at least 1500/mm^3
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Platelet count at least 100,000/mm^3
Hepatic:
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Bilirubin normal
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SGOT/SGPT no greater than 2.5 times upper limit of normal
Renal:
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Creatinine normal OR
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Creatinine clearance at least 60 mL/min
Cardiovascular:
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No symptomatic congestive heart failure
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No unstable angina pectoris
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No cardiac arrhythmia
Other:
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No neuropathy
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
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No allergy to platinum compounds or antiemetics
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No uncontrolled concurrent illness
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No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
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No more than 2 prior chemotherapy regimens
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No prior oxaliplatin or paclitaxel
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At least 4 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
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At least 4 weeks since prior radiotherapy
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No prior radiotherapy to more than 25% of bone marrow
Surgery:
- Not specified
Other:
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No other concurrent investigational agents
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No concurrent antiretroviral therapy for HIV (HAART)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | United States | 43210-1240 |
Sponsors and Collaborators
- Ohio State University Comprehensive Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: Eric H. Kraut, MD, Ohio State University Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OSU-99H0284
- CDR0000067419
- NCI-T99-0017