NCT01664754

Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer

Completed Phase 1 Last updated 7 May 2019

What this trial tests

Phase 1 trial testing exemestane in Stage IV Non-small Cell Lung Cancer in 8 participants. Completed in 11 January 2019.

Timeline

7 September 2012

Primary endpoint
11 January 2019

11 January 2019

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	7 September 2012
Primary completion	11 January 2019
Estimated completion	11 January 2019
Sites	1 location across United States

Drugs / interventions tested

• exemestane (exemestane) — full drug profile →
• pemetrexed disodium — full drug profile →
• carboplatin (Carboplatin) — full drug profile →
• laboratory biomarker analysis — full drug profile →
• pharmacological study — full drug profile →
• questionnaire administration
• quality-of-life assessment

Conditions studied

• Stage IV Non-small Cell Lung Cancer — all drugs for Stage IV Non-small Cell Lung Cancer →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, female only, with Stage IV Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of exemestane in combination with pemetrexed disodium and carboplatin in treating post-menopausal women with stage IV non-small cell lung cancer. Exemestane may stop the growth of tumor calls by blocking some of the enzymes need for cell growth. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving exemestane together with pemetrexed disodium and carboplatin may kill more tumor cells

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Estrogen, Estrogen Receptor and Lung Cancer.
   Hsu LH, Chu NM, Kao SH. · · 2017 · cited 150× · PMID 28783064 · DOI 10.3390/ijms18081713
2. Estrongenic steroid hormones in lung cancer.
   Siegfried JM, Stabile LP. · · 2014 · cited 87× · PMID 24565577 · DOI 10.1053/j.seminoncol.2013.12.009
3. Influence of estrogen in non-small cell lung cancer and its clinical implications.
   Rodriguez-Lara V, Hernandez-Martinez JM, Arrieta O. · · 2018 · cited 77× · PMID 29600083 · DOI 10.21037/jtd.2017.12.61
4. Influence of Estrogen on the NSCLC Microenvironment: A Comprehensive Picture and Clinical Implications.
   Smida T, Bruno TC, Stabile LP. · · 2020 · cited 63× · PMID 32133288 · DOI 10.3389/fonc.2020.00137
5. Randomized phase II study of fulvestrant and erlotinib compared with erlotinib alone in patients with advanced or metastatic non-small cell lung cancer.
   Garon EB, Siegfried JM, Stabile LP, Young PA, et al · · 2018 · cited 32× · PMID 30089602 · DOI 10.1016/j.lungcan.2018.06.013
6. Preclinical Evidence for Combined Use of Aromatase Inhibitors and NSAIDs as Preventive Agents of Tobacco-Induced Lung Cancer.
   Stabile LP, Farooqui M, Kanterewicz B, Abberbock S, et al · · 2018 · cited 30× · PMID 29233790 · DOI 10.1016/j.jtho.2017.11.126
7. Targeting the estrogen pathway for the treatment and prevention of lung cancer.
   Burns TF, Stabile LP. · · 2014 · cited 26× · PMID 25395992 · DOI 10.2217/lmt.13.67
8. Smoking out reproductive hormone actions in lung cancer.
   Siegfried JM. · · 2014 · cited 23× · PMID 24398390 · DOI 10.1158/1541-7786.mcr-13-0580