NCT00100854

Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Completed Phase 2 Last updated 5 March 2019

What this trial tests

Phase 2 trial testing erlotinib hydrochloride in Lung Cancer in 108 participants. Completed in 5 September 2018.

Timeline

28 October 2004

Primary endpoint
5 September 2018

5 September 2018

Quick facts

Lead sponsor	Translational Oncology Research International
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	108
Start date	28 October 2004
Primary completion	5 September 2018
Estimated completion	5 September 2018
Sites	1 location across United States

Drugs / interventions tested

• erlotinib hydrochloride — full drug profile →
• fulvestrant (fulvestrant) — full drug profile →

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

Translational Oncology Research International — full company profile →

Who can join

18 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of non-small cell lung cancer cells. Hormone therapy using fulvestrant may fight non-small cell lung cancer by lowering the amount of estrogen the body makes. Giving erlotinib together with fulvestrant may kill more tumor cells. It is not yet known whether giving erlotinib together with fulvestrant is more effective than erlotinib alone in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying giving erlotinib together with fulvestrant to see how well it works compared to erlotinib alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.

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. 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
3. 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
4. Estrogen signaling in lung cancer: an opportunity for novel therapy.
   Baik CS, Eaton KD. · · 2012 · cited 38× · PMID 24213497 · DOI 10.3390/cancers4040969
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. The role of estrogen, progesterone and aromatase in human non-small-cell lung cancer.
   Kazmi N, Márquez-Garbán DC, Aivazyan L, Hamilton N, et al · · 2012 · cited 23× · PMID 23650476 · DOI 10.2217/lmt.12.44
7. Targeting Estrogens and Various Estrogen-Related Receptors against Non-Small Cell Lung Cancers: A Perspective.
   Maitra R, Malik P, Mukherjee TK. · · 2021 · cited 17× · PMID 35008242 · DOI 10.3390/cancers14010080
8. Novel small molecule EGFR inhibitors as candidate drugs in non-small cell lung cancer.
   Berardi R, Santoni M, Morgese F, Ballatore Z, et al · · 2013 · cited 16× · PMID 23723712 · DOI 10.2147/ott.s28155