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Clinical Trials/NCT00004173
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

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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