Clinical trial · Interventional
Erlotinib Hydrochloride and Irinotecan Hydrochloride in Treating Patients With Advanced Solid Tumors
Phase I Trial of OSI-774 and CPT-11 in Patients With Advanced Solid Tumors
NCT00045201CI-TRIAL-00122226active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Solid Neoplasm | Adult Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib Hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| Irinotecan Hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (enzyme inhibitor, chemotherapy)
- description
- Patients receive oral erlotinib hydrochloride daily on days -6 to -1. Patients then receive irinotecan hydrochloride IV over 90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Erlotinib Hydrochloride
- Drug: Irinotecan Hydrochloride
Primary outcomes (8)
- measure
- MTD of erlotinib hydrochloride and irinotecan hydrochloride in patients with advanced solid tumors that overexpress epidermal growth factor receptor
- timeFrame
- At least 4 weeks
- description
- Defined as the highest safely tolerated dose where at most one patient experiences DLT with the next higher dose having at least 2 patients who experience DLT. Three patients will be entered at a given dose level and observed for at least 4 weeks to assess toxicity. MTD will be determined independently for each cohort.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * No other uncontrolled concurrent illness * No ongoing or active infection * No significant traumatic injury within the past 21 days * No seizure disorder * No psychiatric illness or social situation that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent grapefruit or grapefruit juice * No smoking during study * More than 4 weeks since prior immunotherapy or biologic therapy * No concurrent immunotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No other concurrent chemotherapy * Not specified * More than 4 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of bone marrow * No concurrent radiotherapy * More than 3 weeks since prior major surgery * No prior surgical procedures affecting absorption * No prior EGFR-targeting therapy (e.g., gefitinib or EKB-569) * No other concurrent investigational therapy * No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine, or valproic acid) * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent enrollment on another study involving pharmacological agents for symptom control or therapeutic intent
References
Publications (0)
Data not yet available
No reference posted for this study.