NCT00004173UnknownPhase 1
A Phase I Study of Oxaliplatin in Combination With Paclitaxel
Ohio State University Comprehensive Cancer Center2 sites in 1 countryStarted: October 1, 1999Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Locations
- 2
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •18 and over
- •Performance status:
- •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
- •Bilirubin normal
- •SGOT/SGPT no greater than 2.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •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
- •Not specified
- •No other concurrent investigational agents
- •No concurrent antiretroviral therapy for HIV (HAART)
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
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