Oxaliplatin Injection |
Eloxatin |
Clinical Trial: Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer
This study is no longer recruiting patients.
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| unspecified adult solid tumor, protocol specific | Drug: oxaliplatin Drug: paclitaxel Procedure: chemotherapy | Phase I |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Oxaliplatin and Paclitaxel in Patients With Metastatic or Unresectable Cancer
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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)
Location Information
Ohio
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, 43210-1240, United States
Eric H. Kraut, MD, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: September 2003
Last Updated: October 13, 2004
Record first received: December 10, 1999
ClinicalTrials.gov Identifier: NCT00004173
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Eloxatin (Drug Digest)
- Oxaliplatin Injection (Drug Digest)

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