Protocol Number: 08-C-0086

Title:

A Phase 2, Open-Label, Two Arm Trial to Evaluate the Efficacy of PF-00299804 in Patients with Advanced NSCLC After Failure of at Least One Prior Chemotherapy Regime and Failure of Prior Treatment with Erlotinib

Number:

08-C-0086

Summary:

Background:

Certain chemicals called growth factors can cause cancer cells to grow.

The experimental drug PF-00299804 can block growth factor receptors on the surface of many tumor cells and may, therefore, stop or slow cancer cell growth.

Objectives:

To see if PF-00299804 can shrink lung cancers.

To examine the effects of PF-00299804 on the body.

To learn how the body handles PF-00299804.

To see if PF-00299804 causes changes in blood proteins that are associated with lung cancer cells.

Eligibility:

Patients 18 years of age and older with advanced non small cell lung cancer whose cancer has not been successfully controlled with standard treatments.

Design:

Participants take PF-00299804 tablets by mouth once a day in 21-day treatment cycles. Treatment may continue until the patient's disease worsens or side effects become unacceptable.

In addition to taking the study drug, patients undergo the following tests and procedures at specified intervals:

-Before starting study drug - Medical history, physical and skin exam, height, weight, blood pressure and pulse measurements, blood and urine tests, electrocardiogram (ECG), echocardiogram (ultrasound test of the heart) or MUGA (heart scan), quality of life questionnaire, scans to measure tumor.

-Every cycle - Physical and skin examination, blood and urine tests, blood pressure and pulse measurements, ECG, quality of life questionnaires.

-Cycles 1 and 2 - Blood tests to evaluate how the body handles PF-00299804.

-Every other cycle - Scans or other exams to measure tumor.

-Every fourth cycle - Echocardiogram or MUGA.

-End of study - Physical and skin examination, blood tests, blood pressure and pulse measurements, ECG, quality of life questionnaires, exams to measure tumor.

Participants are followed for at least 1 year after treatment for exams to measure their tumor and monitor their survival.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

For the adenocarcinoma arm, patients with a histologically or cytologically confirmed advanced NSCLC with adenocarcinoma histology (any variant).

For the non-adenocarcinoma arm, patients with a histologically or cytologically confirmed advanced NSCLC with non-adenocarcinoma histology (any variant).

All samples will be reviewed at the NCI Pathology Laboratory.

Patients should have at least one regimen of chemotherapy and erlotinib for advanced NSCLC.

Erlotinib is not considered chemotherapy for purpose of eligibility assessment. Chemotherapy and erlotinib can be part of of one prior combination regimen.

Prior treatment with no more than two chemotherapy regimens, including adjuvant treatment.

Biopsy of primary or metastatic site demonstrating wild type K-ras (performed centrally by Gemzyme).

Patients should have measurable disease.

ECOG 0-1

Patients should have adequate liver, renal, and bone marrow function.

Adequete cardiac function with 12-lead EKG with normal or non significant findings; LVEF greater than or equal to 45% or greater than or equal to institutional lower limit of normal, QTc interval greater than or equal to 470 msec.

Male or female 18 to 99.

EXCLUSION CRITERIA:

No chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of baseline disease assessments.

Children under 18.

Special Instructions:

Currently Not Provided

Keywords:

Advanced NSCLC

KRAS Normal

Recruitment Keyword(s):

Non-Small Cell Lung Cancer

NSCLC

Condition(s):

Normal KRAS

Advanced NSCLC

Normal KRAS

Investigational Drug(s):

PF-0299804

Investigational Device(s):

None

Intervention(s):

Drug: PF-0299804

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Gross ME, Shazer RL, Agus DB.Targeting the HER-kinase axis in cancer.Semin Oncol. 2004 Feb;31(1 Suppl 3):9-20

Barnes CJ, Kumar R.Epidermal growth factor receptor family tyrosine kinases as signal integratorsand therapeutic targets.Cancer Metastasis Rev. 2003 Dec;22(4):301-7.

Albanell J, Codony J, Rovira A, Mellado B, Gascon P. Mechanism of action of anti-HER2 monoclonal antibodies: scientific update on trastuzumab and 2C4. Adv Exp Med Biol. 2003;532:253-68

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