Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors
Completed · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
Drugs used in chemotherapy, such as irinotecan, oxaliplatin, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. This phase I trial is studying the side effects and best dose of irinotecan, oxaliplatin, and capecitabine in treating patients with unresectable solid tumors.
Key facts
- Study ID
- NCT00074321
- Run by
- National Cancer Institute (NCI)
- People needed
- 84
- Starts
- 2003-11-01
- Last updated by the study team
- 2013-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed solid tumor for which there is no known standard therapy that is potentially curative or capable of extending life expectancy
- Unresectable disease
- Willing to provide biologic specimens to determine UGT1A1 genotype
- No CNS metastases
- Prior CNS metastases allowed provided patient was treated with surgery and/or radiotherapy and is stable for more than 8 weeks
- Performance status - ECOG 0-2
- At least 12 weeks
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Hemoglobin at least 9.0 g/dL
- Bilirubin no greater than upper limit of normal (ULN) for patients with 6/6 UGT1A1 genotype (1.5 times ULN for patients with 6/7 [closed to accrual as of 8/24/06] or 7/7 UGT1A1 genotype)
- AST no greater than 3 times ULN (5 times ULN if there is liver involvement)
- Creatinine no greater than 1.5 times ULN
- No New York Heart Association class III or IV heart disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergy to platinum compounds, irinotecan, or to antiemetics or antidiarrheals appropriate for administration with study therapy
- No uncontrolled infection
- No seizure disorder
- No peripheral neuropathy grade 2 or greater
- More than 4 weeks since prior biologic therapy
- More than 4 weeks since prior immunotherapy
- No concurrent immunotherapy
- No concurrent prophylactic colony-stimulating factor therapy
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.