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Home > "O" Clinical Trials Conditions > Oxaliplatin and Gemcitabine in Treating Patients With Advanced Cancer  Oxaliplatin and Gemcitabine in Treating Patients With Advanced Cancer
Oxaliplatin and Gemcitabine in Treating Patients With Advanced Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Beckman Research Institute
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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) --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenShibata, Study Chair, Beckman Research Institute
University of California Davis Cancer Center
Sacramento, California, 95817
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Additional Information:
Study ID Numbers: CDR0000067461; CHNMC-PHI-23,NCI-T99-0003,CHNMC-PHL-23
Study Start Date: October 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004220
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
2. Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain
3. GW786034 in Treating Patients With Advanced Solid Tumors
4. SR-45023A in Treating Patients With Advanced Solid Tumors
5. Chemotherapy in Treating Patients With Advanced Solid Tumors
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Oxaliplatin and Gemcitabine in Treating Patients With Advanced Cancer
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