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| Sponsored by: |
OSI Pharmaceuticals |
| Information provided by: | OSI Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00294762 |
Purpose
This will be the first prospective study where patients will be selected on the basis of two measures of the EGFR pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.
| Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: Tarceva Drug: Tarceva + carboplatin/paclitaxel |
Phase II |
| MedlinePlus related topics: | Cancer Lung Cancer |
| Drug Information available for: | Carboplatin Paclitaxel Erlotinib Erlotinib hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers |
| Estimated Enrollment: | 140 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
150 mg erlotinib qd
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Drug: Tarceva
Erlotinib 150 mg/day
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2: Experimental
carboplatin AUC 6 on Day 1 q 21 days, paclitaxel 200 mg/m2 on Day 1 q 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg qd until progression, withdrawal of consent, or unacceptable toxicity
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Drug: Tarceva + carboplatin/paclitaxel
Intercalated carboplatin/paclitaxel q 21 days + erlotinib 150 mg/d on days 2-15 q 21 days
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Age >= 18 Histologically or cytologically documented NSCSL ECOG PS or 0, 1, 2 Radiologically measurable or evaluable disease
1 or 2 EGFR pathway markers positive at screening Tumor tissue block or fine needle aspirate
Exclusion Criteria:
Any concurrent anticancer therapy or radiation Other active malignancy Uncontrolled brain metastases GI abnormalities Severe abnormalities of the cornea Significant cardiac disease Active infection
Contacts and Locations |
Show 43 Study Locations |
| OSI Pharmaceuticals |
More Information
Sponsor's website
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| Responsible Party: | OSI Pharmaceuticals, Inc. ( Karsten Witt, MD, VP Clinical Development ) |
| Study ID Numbers: | OSI-774-203 |
| First Received: | February 17, 2006 |
| Last Updated: | October 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00294762 |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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