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Home > "O" Clinical Trials Conditions > Oxaliplatin Plus Capecitabine in Treating Patients With Metastatic or Recurrent Solid Tumor  Oxaliplatin Plus Capecitabine in Treating Patients With Metastatic or Recurrent Solid Tumor
Oxaliplatin Plus Capecitabine in Treating Patients With Metastatic or Recurrent Solid Tumor
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 combined with capecitabine in treating patients who have metastatic or recurrent solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in combination with oxaliplatin in patients with metastatic or recurrent solid tumors. II. Determine the toxicities of this treatment regimen in this patient population. PROTOCOL OUTLINE: This is a dose escalation study of capecitabine. Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for disease progression and survival. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed metastatic or recurrent solid tumor that has failed standard therapy or for which no standard therapy exists No known brain metastases or carcinomatosis meningitis --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered Prior fluorouracil or cisplatin allowed Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgery Other: At least 30 days since prior investigational drugs No concurrent antiretroviral therapy (HAART) --Patient Characteristics-- Age: 18 and over Performance status: SWOG 0-2 Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2.5 times normal Renal: Creatinine normal OR Creatinine clearance greater than 60 mL/min Calcium no greater than 12 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No evidence of neuropathy No history of allergies to platinum compounds or antiemetics that would preclude study No other uncontrolled illness (e.g., ongoing or active infection) No medical, social, or psychological factors that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Heinz-JosefLenz, Study Chair, Beckman Research Institute
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
Additional Information:
Study ID Numbers: CDR0000067854; CHNMC-IRB-99130,CHNMC-PHI-25,NCI-T99-0005
Study Start Date: August 2000
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005839
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
2. CCI-779 in Treating Patients With Advanced Solid Tumors
3. PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
4. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
5. Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Oxaliplatin Plus Capecitabine in Treating Patients With Metastatic or Recurrent Solid Tumor
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