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Oxaliplatin and Gemcitabine in Treating Patients With Advanced Cancer

This study has been completed.

Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004220
  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 gemcitabine in treating patients who have advanced cancer.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: gemcitabine hydrochloride
Drug: oxaliplatin
Phase I

MedlinePlus related topics:   Cancer   

Drug Information available for:   Gemcitabine hydrochloride    Gemcitabine    Oxaliplatin   

U.S. FDA Resources

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

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

Study Start Date:   October 1999

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicities of gemcitabine in combination with oxaliplatin in patients with advanced malignancies. II. Determine the pharmacokinetics of oxaliplatin and gemcitabine in these patients.

OUTLINE: This is a multicenter, dose escalation study of gemcitabine. Patients receive oxaliplatin IV over 2 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination with a fixed dose of oxaliplatin 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: A total of 24-36 patients will be accrued for this study within 2 years.

  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 therapy does not exist or is no longer effective No greater than 3 prior treatment regimens No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 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 clinically significant neuropathy Not pregnant or nursing Fertile patients must use effective contraception No allergy to platinum compounds or antiemetics No uncontrolled active infection or other illness

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No prior radiotherapy to at least 30% of bone marrow At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agents No other concurrent anticancer therapy No HIV positive patients receiving antiretroviral therapy (HAART)

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004220

Locations
United States, California
Cancer Center and Beckman Research Institute, City of Hope    
      Duarte, California, United States, 91010-3000
University of California Davis Cancer Center    
      Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital    
      Los Angeles, California, United States, 90033-0804

Sponsors and Collaborators
Beckman Research Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     Stephen I. Shibata, MD     Beckman Research Institute    
  More Information


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

Study ID Numbers:   CDR0000067461, CHNMC-PHI-23, CHNMC-PHL-23, NCI-T99-0003
First Received:   January 28, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004220
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific  

Study placed in the following topic categories:
Oxaliplatin
Gemcitabine

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2008




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