A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue to Smoke After Failure of One or Two Prior Chemotherapy Regimens

NCT00294736 | Completed Phase 1 DMC

• 2 other identifiers: OSI-774-1072005-003883-46
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 9

Brief Summary

This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in patients with advanced NSCLC who currently smoke. Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers. In Part II, patients will be randomized 1:1 to two treatment groups: Arm A (Tarceva MTD established in Part I) and Arm B (150 mg Tarceva daily). Patients in both arms will be treated for two weeks and then have pharmacokinetic samples collected on day 14. Part II is open as of Nov-2006.

Conditions

NSCLC

Keywords

lung cancer; erlotinib; NSCLC; smokers

Outcome Measures

Primary Outcomes (1)

• To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC.

  2 years

Secondary Outcomes (1)

• To evaluate the survival of currently smoking patients with stage IIIB/IV NSCLC when given Tarceva at the MTD and 150 mg.

  2 years

Study Arms (2)

Arm A

EXPERIMENTAL

Arm A (Tarceva MTD established in Part I)

Drug: Tarceva

Arm B

EXPERIMENTAL

Arm B (150 mg Tarceva daily).

Drug: Tarceva

Interventions

Tarceva DRUG

Dose Escalation: 150-350+ mg/day

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of stage IIIB/IV NSCLC;
• Must have received 1 or 2 prior chemotherapy regimens for advanced NSCLC and now have progressive disease;
• Must have recovered from any treatment-related toxicities prior to registration, except for alopecia, grade 1 fatigue, or grade 1 neurotoxicity;
• A current cigarette smoker (minimum of 10 cigarettes per day for \>= 1 year and have a positive test for cotinine) despite advice and support to quit;
• Age \>= 18 years;
• ECOG PS 0-1 and predicted life expectancy \>= 12 weeks;
• Previous surgery is permitted provided that wound healing has occurred prior to registration;
• Adequate hematopoietic, hepatic and renal function defined as follows: ANC \>= 1.5 x 10\^9/L, platelets \>= 100 x 10\^9/L, bilirubin \<= 1.5 x ULN, ALT \<= 2.5 x ULN (or 5 x ULN in case of liver metastases), creatinine \<= 1.5 x ULN;
• No prior treatment with Tarceva or gefitinib (or other drug with significant activity against EGFR (eg, cetuximab and/or ZD6474));
• Patients with reproductive potential must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test within 14 days prior to registration;
• Accessible for repeat dosing and follow-up.

You may not qualify if:

• Any concurrent anticancer cytostatic or cytotoxic chemotherapy;
• Concomitant CYP3A4 or CYP1A2 inducers/inhibitors (or during 14 days prior to study) with the exception of tobacco;
• Other active malignancies, unless disease-free and without cancer-specific therapy for at least the last 5 years. Basal or squamous cell skin cancers are not excluded;
• Significant history of cardiac disease unless the disease is well-controlled;
• Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study;
• History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements; of the study or to provide informed consent.
• Gastrointestinal abnormalities, including inability to take oral medication, requirement for IV alimentation, active peptic ulcer or prior surgical procedures affecting absorption;
• Clinically significant ophthalmologic abnormalities;
• Pregnant or breast-feeding females. Males or females not practicing effective birth control;
• Symptomatic brain metastases which are not stable, require steroids, or that have required radiation within the last 28 days;
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug;

Sponsors & Collaborators

• OSI Pharmaceuticals: lead

Study Sites (9)

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Edinburgh,Division of Oncology,

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Sir Bobby Robson Cancer Trials Research Centre

Newcastle upon Tyne, NE7 7DH, United Kingdom

Location

Department of Oncology

Sheffield, S10 2SJ, United Kingdom

Location

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Monitor

  OSI Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2006
• First Posted: February 22, 2006
• Study Start: November 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: August 8, 2012

Record last verified: 2012-08

Locations

US (2); GB (7)