Clinical trial NCT00139620: A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function
Official title: An Open-Label Study to Characterize the Pharmacokinetic Parameters of Erlotinib (Tarceva®, OSI-774) in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: advanced cancer, solid tumor
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, 2-arm study comparing erlotinib exposure in cancer patients with adequate hepatic function versus cancer patients with moderate hepatic impairment. All patients will receive a single 150 mg dose of erlotinib on Day 1 followed by 96 hours of plasma sampling for PK and protein binding studies. Patients may then enter the maintenance phase of the study and continue to receive erlotinib until disease progression or unacceptable toxicity.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed advanced solid tumor (measurable or nonmeasurable) that is potentially responsive to erlotinib or for which no effective therapy is available,
* Cohort 1: Adequate hepatic function: bilirubin \<= ULN, ALT (SGPT) and AST (SGOT) \<= 1.5 x ULN or Cohort 2: Moderate hepatic function: 7-9 as assessed by the Child-Pugh System, ECOG Performance Status 0-2
* Life expectancy \>= 12 weeks,
* Prior radiation permitted provided that 4 weeks (or 2 weeks for palliative radiation) has elapsed and patients have recovered from acute toxic effects of radiotherapy,
* Prior chemotherapy permitted provided that 4 weeks has elapsed and patients have recovered from acute toxic effects of chemotherapy,
* Adequate hematopoietic and renal function: ANC \>= 1.5 x 10\^9/L, platelets \>= 75 x 10\^9/L, and creatinine \<= 1.5 x ULN,

Exclusion Criteria:

* Use of tobacco or nicotine-containing products within 4 weeks of Day 1 and while on study,
* Use of a CYP3A4 inhibitor or inducer within 14 days prior to Day 1 and until Day 5,
* Use of a warfarin-derivative anticoagulant within 14 days prior to Day 1 and until Day 5,
* Encephalopathy \>= grade 2,
* Significant history of cardiac disease unless well-controlled,
* Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation,
* Concurrent anticancer therapy or any other investigational agents within 4 weeks of Day 1 and while on study,
* Symptomatic brain metastases that are not stable, require steroids, are potentially life-threatening, or that have required radiation within the last 4 weeks,
* Gastro-intestinal abnormalities, including inability to take oral medication, requirement for IV alimentation, active peptic ulcer or prior surgical procedures affecting absorption.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Premiere Oncology
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Pittsburgh
country: United States
facility: UPMC Cancer Pavilion
state: Pennsylvania
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
Study officials:
References: