Lung Cancer
A Phase II, 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
NCI-08-C-0086
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Investigator(s): |
Giuseppe Giaccone, M.D., Ph.D.
Principal Investigator
Phone: 301-496-4916
Fax: 301-402-0172
giacconeg@mail.nih.gov
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Arlene Berman, R.N., M.S., O.C.N.
Research Nurse
Phone: 301-435-5609
arleneb@mail.nih.gov
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Primary Eligibility:
- 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 one prior combination regimen
- No more than two chemotherapy regimens, including adjuvant treatment
- Biopsy of primary or metastatic site demonstrating wild type K-ras (performed centrally by Gemzyme)
- No chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of baseline disease assessments
- Measurable disease
- ≥ 18 years of age
- ECOG 0–1
- Adequate liver, renal, and bone marrow function
- Adequate cardiac function:
- 12-lead EKG with normal or nonsignificant findings
- LVEF ≥ 45% or ≥ institutional lower limit of normal
- QTc interval ≤ 470 msec
Treatment Plan:
- All patients take 45mg of PF-00299804 orally once daily for a cycle that is defined as 21 days
- Pharmacokinetics will be collected in Cycle 1 and Cycle 2
- 44 response-evaluable adenocarcinoma patients and 22 evaluable non-adenocarcinoma patients will be enrolled in the study
- Blood for biomarkers will be drawn at baseline, at Cycle 2, and when the patient ends the study
- Quality of life questionnaires will be done at baseline and prior to every cycle
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 10/14/08
Updated: 11/3/08
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