Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer - Full Text View

Sponsor:	Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004173

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	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: oxaliplatin Drug: paclitaxel	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Study of Oxaliplatin in Combination With Paclitaxel

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Paclitaxel Oxaliplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 1999

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.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12-18 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004173

Locations

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

Sponsors and Collaborators

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Eric H. Kraut, MD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067419, OSU-99H0284, NCI-T99-0017
Study First Received:	December 10, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00004173 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Oxaliplatin
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Paclitaxel
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 11, 2009