N/A
Completed N=12
Study of Tarceva and Targretin in Stage I-II Lung Cancer
Source: ClinicalTrials.gov NCT00125372 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants With Change in Expression Level of EGFR. — 3; 7 Participants
Summary
The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Change in Expression Level of EGFR. |
3; 7 | — |
| PRIMARY Number of Participants With Change in Expression Level of Cyclin D1 |
6; 4 | — |
| PRIMARY Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR) |
6; 4 | — |
| SECONDARY Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels |
— | — |
| SECONDARY Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response |
4; 4; 1; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Resectable stage I or II non-small-cell lung cancer
- Prior tissue biopsy (not cytology) available for research analysis
- Adequate hepatic and renal function
Exclusion Criteria
- Prior chemotherapy or radiotherapy
Data sourced from ClinicalTrials.gov (NCT00125372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.