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.

Condition	Treatment or Intervention	Phase
Pancreatic Cancer Gastric Cancer Esophageal Cancer Colorectal Cancer adult primary liver cancer Colon Cancer Rectal Cancer Breast Cancer	Drug: capecitabine  Drug: irinotecan	Phase I

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States

Study chairs or principal investigators

Sridhar Mani,  Study Chair,  Albert Einstein Cancer Research Center   

Study ID Numbers:  CDR0000067031; AECM-1199903068; NCI-V99-1541
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003867
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08