Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active Over 18 NCI UCLA-0407058-01 NCT00100854

Special Category: SPORE trial

Objectives

Primary

1. Compare objective tumor response in patients stage IIIB or IV non-small cell lung cancer treated with erlotinib hydrochloride with vs without fulvestrant.

Secondary

1. Correlate response rate with ER and EGF receptor expression in patients treated with these regimens.
2. Correlate measurement of ER-α, ER-β, EGF/HER-1 receptor and HER-2/neu receptor with clinical response in patients treated with these regimens.
3. Correlate erlotinib hydrochloride resistance with ER and HER receptor expression in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-small cell lung cancer
  • Stage IIIB or IV disease



• Measurable disease by RECIST criteria defined as ≥ 1 target lesion that has not been irradiated
  • New lesions that have developed in a previously irradiated field may be used as sites of measurable disease provided all other criteria are met



• Meets 1 of the following criteria:
  • Progressive disease after ≥ 1 prior standard chemotherapy regimen
  • Refused chemotherapy
  • Unable to receive standard chemotherapy



• Tumor tissue block must be available



• No active CNS metastasis

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy

Endocrine therapy

• No prior anticancer antiestrogen therapy
• Concurrent stable-dose steroids allowed

Radiotherapy

• More than 1 week since prior radiotherapy to non-target lesions
• No concurrent radiotherapy to the lungs

Surgery

• At least 7 days since prior surgery and recovered

Other

• No prior anticancer epidermal growth factor receptor inhibitors
• More than 4 weeks since prior non-cytotoxic investigational agents
• No concurrent CYP3A4 inducers, including any of the following:
  • Phenytoin
  • Carbamazepine
  • Rifampin
  • Barbiturates
  • Hypericum perforatum (St. John's wort)

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin ≤ 1.5 mg/dL
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• PT and/or PTT ≤ 1.5 times ULN

Renal

• Creatinine ≤ 2 mg/dL

Cardiovascular

• No New York Heart Association class III or IV cardiac disease
• No myocardial infarction within the past 12 months
• No symptomatic ventricular arrhythmia
• No symptomatic conduction abnormality

Pulmonary

• No evidence of clinically active interstitial lung disease
  • Patients with asymptomatic chronic stable radiographic changes are eligible

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No hypersensitivity to erlotinib hydrochloride or fulvestrant or to any of their excipients
• No other comorbid disease or medical condition that would preclude study treatment or compliance
• No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

Expected Enrollment

A total of 102 patients (34 in arm I and 68 in arm II) will be accrued for this study.

Outcomes

Objective tumor response

Correlation of response rate with receptor expression
Correlation of receptor measurements with clinical response
Correlation of erlotinib hydrochloride resistance with receptor expression

Outline

This is a randomized, open-label, multicenter study. Patients are stratified according to performance status, gender, and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days.



• Arm II: Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1, 15, and 29, and then every 28 days thereafter.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30 days and then every 2 months until disease progression.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Edward Garon, MD, Principal investigator		Ph: 310-206-0135; 888-798-0719 Email: egaron@mednet.ucla.edu

U.S.A.
California
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA	Ph:  888-798-0719

Registry Information
Official Title		A Randomized, Open-Label Phase II Clinical Trial of Combination Erlotinib (Tarceva®) and Fulvestrant (Faslodex®) versus Erlotinib (Tarceva®) Alone in Advanced Non-Small Cell Lung Cancer Patients
Trial Start Date		2004-10-28
Trial Completion Date		2011-10-28 (estimated)
Registered in ClinicalTrials.gov		NCT00100854
Date Submitted to PDQ		2004-11-18
Information Last Verified		2008-01-11
NCI Grant/Contract Number		CA16042, CA90388