Pemetrexed plus cetuximab in patients with recurrent non-small cell lung cancer (NSCLC): A phase I/II study from the hoosier oncology group

Shadia Jalal, David Waterhouse, Martin J. Edelman, Sreenivasa Nattam, Rafat Ansari, Karuna Koneru, Romnee Clark, Arthur Richards, Jingwei Wu, Menggang Yu, Brian Bottema, Angela White, Nasser Hanna

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Purpose: Pemetrexed is a standard treatment against recurrent non-small cell lung cancer (NSCLC), and cetuximab has single-agent activity against NSCLC. This study evaluates the safety and efficacy of the combination of these agents in patients with advanced NSCLC. Patients and Methods: Patients with recurrent NSCLC and an Eastern Cooperative Oncology Group performance status of 0 to 1 were entered. Patients on the phase I portion of the study received cetuximab 400 mg/m2 intravenously (IV) on day -7 followed by weekly doses of cetuximab at 250 mg/m2 IV with escalating doses of pemetrexed every 3 weeks (dose levels: 500, 600, 750, 900 mg/m2) in a standard 3 + 3 design. Once the maximum tolerated dose (MTD) of the combination was determined, patients were enrolled on the phase II portion. The primary end point was to determine the median time to disease progression (TTP) (null hypothesis 12 weeks, alternative hypothesis 24 weeks). Results: Thirty-six patients were enrolled (phase I: n = 13, phase II: n = 23). Patient characteristics included 60.6% men, median age 64 years (range, 37-80 years), 57.6% had performance status 0 and 54.6% had adenocarcinoma histology. The median number of previous regimens was 2 (range, 1-6). The maximum tolerated dose of pemetrexed in combination with cetuximab was determined to be 750 mg/m2. The median TTP was 14.6 weeks. The median survival time was 42 weeks and 1-year survival was 38.5%. Conclusion: The combination of pemetrexed at 750 mg/m2 every 21 days with weekly cetuximab at 250 mg/m2 was feasible; however, in this unselected patient population, the combination regimen does not seem to improve TTP compared with historical controls of either single agent.

Original languageEnglish
Pages (from-to)1420-1424
Number of pages5
JournalJournal of Thoracic Oncology
Volume4
Issue number11
DOIs
StatePublished - Nov 2009

Fingerprint

Pemetrexed
Non-Small Cell Lung Carcinoma
Disease Progression
Maximum Tolerated Dose
Survival
Proxy
Cetuximab
Histology
Adenocarcinoma
Safety

Keywords

  • Cetuximab
  • Pemetrexed
  • Recurrent non-small cell

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Pemetrexed plus cetuximab in patients with recurrent non-small cell lung cancer (NSCLC) : A phase I/II study from the hoosier oncology group. / Jalal, Shadia; Waterhouse, David; Edelman, Martin J.; Nattam, Sreenivasa; Ansari, Rafat; Koneru, Karuna; Clark, Romnee; Richards, Arthur; Wu, Jingwei; Yu, Menggang; Bottema, Brian; White, Angela; Hanna, Nasser.

In: Journal of Thoracic Oncology, Vol. 4, No. 11, 11.2009, p. 1420-1424.

Research output: Contribution to journalArticle

Jalal, Shadia ; Waterhouse, David ; Edelman, Martin J. ; Nattam, Sreenivasa ; Ansari, Rafat ; Koneru, Karuna ; Clark, Romnee ; Richards, Arthur ; Wu, Jingwei ; Yu, Menggang ; Bottema, Brian ; White, Angela ; Hanna, Nasser. / Pemetrexed plus cetuximab in patients with recurrent non-small cell lung cancer (NSCLC) : A phase I/II study from the hoosier oncology group. In: Journal of Thoracic Oncology. 2009 ; Vol. 4, No. 11. pp. 1420-1424.
@article{765c1a5026ae45f89cbdba1054fd729c,
title = "Pemetrexed plus cetuximab in patients with recurrent non-small cell lung cancer (NSCLC): A phase I/II study from the hoosier oncology group",
abstract = "Purpose: Pemetrexed is a standard treatment against recurrent non-small cell lung cancer (NSCLC), and cetuximab has single-agent activity against NSCLC. This study evaluates the safety and efficacy of the combination of these agents in patients with advanced NSCLC. Patients and Methods: Patients with recurrent NSCLC and an Eastern Cooperative Oncology Group performance status of 0 to 1 were entered. Patients on the phase I portion of the study received cetuximab 400 mg/m2 intravenously (IV) on day -7 followed by weekly doses of cetuximab at 250 mg/m2 IV with escalating doses of pemetrexed every 3 weeks (dose levels: 500, 600, 750, 900 mg/m2) in a standard 3 + 3 design. Once the maximum tolerated dose (MTD) of the combination was determined, patients were enrolled on the phase II portion. The primary end point was to determine the median time to disease progression (TTP) (null hypothesis 12 weeks, alternative hypothesis 24 weeks). Results: Thirty-six patients were enrolled (phase I: n = 13, phase II: n = 23). Patient characteristics included 60.6{\%} men, median age 64 years (range, 37-80 years), 57.6{\%} had performance status 0 and 54.6{\%} had adenocarcinoma histology. The median number of previous regimens was 2 (range, 1-6). The maximum tolerated dose of pemetrexed in combination with cetuximab was determined to be 750 mg/m2. The median TTP was 14.6 weeks. The median survival time was 42 weeks and 1-year survival was 38.5{\%}. Conclusion: The combination of pemetrexed at 750 mg/m2 every 21 days with weekly cetuximab at 250 mg/m2 was feasible; however, in this unselected patient population, the combination regimen does not seem to improve TTP compared with historical controls of either single agent.",
keywords = "Cetuximab, Pemetrexed, Recurrent non-small cell",
author = "Shadia Jalal and David Waterhouse and Edelman, {Martin J.} and Sreenivasa Nattam and Rafat Ansari and Karuna Koneru and Romnee Clark and Arthur Richards and Jingwei Wu and Menggang Yu and Brian Bottema and Angela White and Nasser Hanna",
year = "2009",
month = "11",
doi = "10.1097/JTO.0b013e3181b624ae",
language = "English",
volume = "4",
pages = "1420--1424",
journal = "Journal of Thoracic Oncology",
issn = "1556-0864",
publisher = "International Association for the Study of Lung Cancer",
number = "11",

}

TY - JOUR

T1 - Pemetrexed plus cetuximab in patients with recurrent non-small cell lung cancer (NSCLC)

T2 - A phase I/II study from the hoosier oncology group

AU - Jalal, Shadia

AU - Waterhouse, David

AU - Edelman, Martin J.

AU - Nattam, Sreenivasa

AU - Ansari, Rafat

AU - Koneru, Karuna

AU - Clark, Romnee

AU - Richards, Arthur

AU - Wu, Jingwei

AU - Yu, Menggang

AU - Bottema, Brian

AU - White, Angela

AU - Hanna, Nasser

PY - 2009/11

Y1 - 2009/11

N2 - Purpose: Pemetrexed is a standard treatment against recurrent non-small cell lung cancer (NSCLC), and cetuximab has single-agent activity against NSCLC. This study evaluates the safety and efficacy of the combination of these agents in patients with advanced NSCLC. Patients and Methods: Patients with recurrent NSCLC and an Eastern Cooperative Oncology Group performance status of 0 to 1 were entered. Patients on the phase I portion of the study received cetuximab 400 mg/m2 intravenously (IV) on day -7 followed by weekly doses of cetuximab at 250 mg/m2 IV with escalating doses of pemetrexed every 3 weeks (dose levels: 500, 600, 750, 900 mg/m2) in a standard 3 + 3 design. Once the maximum tolerated dose (MTD) of the combination was determined, patients were enrolled on the phase II portion. The primary end point was to determine the median time to disease progression (TTP) (null hypothesis 12 weeks, alternative hypothesis 24 weeks). Results: Thirty-six patients were enrolled (phase I: n = 13, phase II: n = 23). Patient characteristics included 60.6% men, median age 64 years (range, 37-80 years), 57.6% had performance status 0 and 54.6% had adenocarcinoma histology. The median number of previous regimens was 2 (range, 1-6). The maximum tolerated dose of pemetrexed in combination with cetuximab was determined to be 750 mg/m2. The median TTP was 14.6 weeks. The median survival time was 42 weeks and 1-year survival was 38.5%. Conclusion: The combination of pemetrexed at 750 mg/m2 every 21 days with weekly cetuximab at 250 mg/m2 was feasible; however, in this unselected patient population, the combination regimen does not seem to improve TTP compared with historical controls of either single agent.

AB - Purpose: Pemetrexed is a standard treatment against recurrent non-small cell lung cancer (NSCLC), and cetuximab has single-agent activity against NSCLC. This study evaluates the safety and efficacy of the combination of these agents in patients with advanced NSCLC. Patients and Methods: Patients with recurrent NSCLC and an Eastern Cooperative Oncology Group performance status of 0 to 1 were entered. Patients on the phase I portion of the study received cetuximab 400 mg/m2 intravenously (IV) on day -7 followed by weekly doses of cetuximab at 250 mg/m2 IV with escalating doses of pemetrexed every 3 weeks (dose levels: 500, 600, 750, 900 mg/m2) in a standard 3 + 3 design. Once the maximum tolerated dose (MTD) of the combination was determined, patients were enrolled on the phase II portion. The primary end point was to determine the median time to disease progression (TTP) (null hypothesis 12 weeks, alternative hypothesis 24 weeks). Results: Thirty-six patients were enrolled (phase I: n = 13, phase II: n = 23). Patient characteristics included 60.6% men, median age 64 years (range, 37-80 years), 57.6% had performance status 0 and 54.6% had adenocarcinoma histology. The median number of previous regimens was 2 (range, 1-6). The maximum tolerated dose of pemetrexed in combination with cetuximab was determined to be 750 mg/m2. The median TTP was 14.6 weeks. The median survival time was 42 weeks and 1-year survival was 38.5%. Conclusion: The combination of pemetrexed at 750 mg/m2 every 21 days with weekly cetuximab at 250 mg/m2 was feasible; however, in this unselected patient population, the combination regimen does not seem to improve TTP compared with historical controls of either single agent.

KW - Cetuximab

KW - Pemetrexed

KW - Recurrent non-small cell

UR - http://www.scopus.com/inward/record.url?scp=70449553199&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=70449553199&partnerID=8YFLogxK

U2 - 10.1097/JTO.0b013e3181b624ae

DO - 10.1097/JTO.0b013e3181b624ae

M3 - Article

C2 - 19701110

AN - SCOPUS:70449553199

VL - 4

SP - 1420

EP - 1424

JO - Journal of Thoracic Oncology

JF - Journal of Thoracic Oncology

SN - 1556-0864

IS - 11

ER -