Stage IIIA Non-Small Cell Lung Cancer Clinical Trial
Official title:
Pioglitazone as a Candidate Chemoprevention Agent for Lung Cancer: A Pilot Trial Using a Pre-surgical Model in Early Stage NSCLC
This pilot phase II trial studies how well pioglitazone works in treating patients with stage IA-IIIA non-small cell lung cancer. Pioglitazone hydrochloride may slow the growth of tumor cells and may be an effective treatment for non-small cell lung cancer.
PRIMARY OBJECTIVES:
I. To evaluate the mechanism(s) of action of pioglitazone as a candidate chemopreventive
agent for lung cancer by investigating the effects on Ki-67 defined in non-small cell lung
cancer (NSCLC) tumor tissue.
SECONDARY OBJECTIVES:
I. To determine the effects of pioglitazone on multiple markers listed below:
- Tumor tissue: caspase-3, cyclin D1, p21/Waf1, peroxisome proliferative activated
receptor, gamma (PPARγ), mucin 1 (MUC1).
- Premalignant tissue: Ki-67, caspase-3, PPARγ.
- Histologically normal tissue: Ki-67, PPARγ. II. To evaluate the toxicity and safety of
pioglitazone in this patient population.
III. To analyze the expression of serum markers that are affected by pioglitazone.
IV. To describe the effects of limited treatment with pioglitazone on tumor metabolic
activity as determined by FDG-PET (assessed before and after a minimum of 2 weeks of
treatment).
OUTLINE:
Patients receive pioglitazone hydrochloride orally (PO) once daily (QD) for 14-42 days.
Patients then undergo surgery.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01711697 -
An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
| Completed |
NCT02364609 -
Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib
|
Phase 1 | |
| Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT01935336 -
Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers
|
Phase 2 | |
| Withdrawn |
NCT01971489 -
Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00963807 -
Trial Comparing the Use of FLT PET to Standard CT to Assess Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable NSCLC
|
Phase 2 | |
| Completed |
NCT00093756 -
Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00049543 -
Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery
|
Phase 3 | |
| Completed |
NCT02879994 -
Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
| Completed |
NCT02897375 -
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT02566421 -
Genomic Sequencing in Determining Treatment in Patients With Metastatic Cancer or Cancer That Cannot Be Removed by Surgery
|
N/A | |
| Withdrawn |
NCT02017925 -
Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation
|
N/A | |
| Terminated |
NCT01707823 -
Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
|
Early Phase 1 | |
| Terminated |
NCT01411098 -
Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
|
Phase 1 | |
| Terminated |
NCT00738881 -
Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer
|
Phase 3 | |
| Completed |
NCT00778167 -
Erlotinib Hydrochloride With or Without Cixutumumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00074022 -
GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT01857271 -
Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer
|
Phase 2 | |
| Terminated |
NCT01413750 -
Carboplatin and Paclitaxel With or Without Vorinostat in Treating Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 1/Phase 2 |