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Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer - Article


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Oxaliplatin Injection

Eloxatin 




Clinical Trial: Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

OBJECTIVES:

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:


Location Information


Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000067419; OSU-99H0284; NCI-T99-0017
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

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November 30, 2009



Page Updated: June 1, 2005
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