Erlotinib Hydrochloride and Irinotecan Hydrochloride in Treating Patients With Advanced Solid Tumors
Running, not enrolling · Phase 1
Conditions studied: Adult Solid Neoplasm
In brief
Phase I trial to study the effectiveness of combining erlotinib hydrochloride with irinotecan hydrochloride in treating patients who have advanced solid tumors. Erlotinib hydrochloride may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib hydrochloride and chemotherapy may kill more tumor cells.
Key facts
- Study ID
- NCT00045201
- Run by
- National Cancer Institute (NCI)
- People needed
- 60
- Starts
- 2002-06-13
- Expected to finish
- 2026-08-22
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed malignancy that overexpresses epidermal growth factor receptor (EGFR)
- Unresectable disease for which there is no known standard therapy that ispotentially curative or definitely capable of extending life expectancy
- UGT1A1 genotype 6/6, 6/7, or 7/7
- Willing to provide biologic specimens
- Lesions amenable for 2 biopsies from the same tumor site (only patients receiving MTD in groups 2 and 3)
- No known brain metastases
- 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 1.5 times upper limit of normal (ULN)
- AST ≤ 2.5 times ULN (5 times ULN if liver metastases present)
- Creatinine no greater than 1.5 times ULN
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No New York Heart Association class III or IV heart disease
- No gastrointestinal tract disease resulting in an inability to take oral or nasogastric medication
- No requirement for IV alimentation
- No active peptic ulcer disease
- No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
- No congenital abnormality (e.g., Fuch's dystrophy)
- No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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