Full Text View
Tabular View
No Study Results Posted
Related Studies
Oxaliplatin and Gemcitabine in Treating Patients With Advanced Cancer
This study has been completed.
First Received: January 28, 2000   Last Updated: July 23, 2008   History of Changes
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: Oxaliplatin Gemcitabine Gemcitabine hydrochloride
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
Investigators
Study Chair: Stephen I. Shibata, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067461, CHNMC-PHI-23, CHNMC-PHL-23, NCI-T99-0003
Study First Received: January 28, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004220     History of Changes
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:
Antimetabolites
Oxaliplatin
Radiation-Sensitizing Agents
Immunologic Factors
Gemcitabine
Immunosuppressive Agents
Antiviral Agents

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
Oxaliplatin
Radiation-Sensitizing Agents
Therapeutic Uses
Gemcitabine

ClinicalTrials.gov processed this record on May 07, 2009