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Home > "I" Clinical Trials Conditions > Irinotecan and Capecitabine in Treating Patients With Solid Tumors  Irinotecan and Capecitabine in Treating Patients With Solid Tumors
Irinotecan and Capecitabine in Treating Patients With Solid Tumors
For Condition: Gastric Cancer,adult primary liver cancer,Rectal Cancer,Esophageal Cancer,Colon Cancer,Breast Cancer,Pancreatic Cancer,Colorectal Cancer
Status: No longer recruiting
Sponsor(s): Albert Einstein Cancer Research Center ,
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 irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and toxic effects of irinotecan and oral capecitabine in patients with gastrointestinal or other solid tumors. II. Characterize the relationship at the recommended phase II dose between thymidine synthase and thymidine phosphorylase expression and tumor response and/or toxic effects in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive oral capecitabine twice daily every twelve hours for 14 days, and IV irinotecan over 30 minutes once every 3 weeks beginning on day 1. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. The dose of capecitabine and irinotecan is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: Approximately 25-30 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 confirmed solid tumors, including but not limited to breast, gastrointestinal, and unknown primary cancer that is refractory to standard therapy or for which no standard therapy exists - No known bone marrow involvement --Prior/Concurrent Therapy-- - Biologic therapy: At least 2 weeks since prior colony stimulating factor and other cytokines active on bone marrow - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas); No prior or concurrent irinotecan and fluorouracil therapy - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy; No concurrent radiotherapy - Surgery: Recovered from prior major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3 OR WBC at least 3,500/mm3 AND Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; No known Gilbert's syndrome; No other significant hepatic disease requiring medication - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No significant cardiac disease requiring medication - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other significant medical condition
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SridharMani, Study Chair, Albert Einstein Cancer Research Center
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Additional Information:
Study ID Numbers: CDR0000067031; AECM-1199903068,NCI-V99-1541
Study Start Date: March 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003867
Other Colorectal Cancer Studies:
1. Irinotecan and Capecitabine in Treating Patients With Solid Tumors
2. Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
3. Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer
4. Biological Therapy in Treating Patients With Metastatic Cancer
5. Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer
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Irinotecan and Capecitabine in Treating Patients With Solid Tumors
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