A Phase I Study of Oxaliplatin in Combination With Paclitaxel
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study of Oxaliplatin in Combination With Paclitaxel
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.
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:
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)
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Eric H. Kraut, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ohio State University Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
OSU-99H0284
NCT ID:
NCT00004173
Start Date:
October 1999
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
