Erlotinib Hydrochloride and Irinotecan Hydrochloride in Treating Patients With Advanced Solid Tumors

• Status: Active, not recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Camptothecin; Erlotinib Hydrochloride; Irinotecan

Criteria

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