Phase II study of gemcitabine, oxaliplatin, and cetuximab in advanced pancreatic cancer

Jaime R Merchan, Annaporna Ferrell, Jessica MacIntyre, Kristen K. Ciombor, Joe Levi, Afonso Ribeiro, Danny Sleeman, Aurea Flores, Gilberto Lopes, Caio M. Rocha-Lima

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

OBJECTIVE: Little progress has been made in the treatment of pancreatic cancer (PC). This study evaluated the clinical activity of gemcitabine, oxaliplatin, and cetuximab (GOC) in patients with locally advanced or metastatic PC. METHODS: The study primary endpoint was progression-free survival (PFS). Eligible, chemotherapy-naive PC patients were treated with gemcitabine (1000 mg/m over 100 min) on day 1, oxaliplatin (100 mg/m) on day 2, every 2 weeks, and weekly cetuximab, (loading dose of 400 mg/m on cycle 1 day 1 and 250 mg/m thereafter). It was expected that GOC treatment would extend the median PFS from 5.8 to 7.54 months, a relative increase of 30%, compared with gemcitabine and oxaliplatin (historical control). RESULTS: A total of 41 evaluable patients were enrolled. The overall response rate was 24%. Median PFS time was 6.9 months and median overall survival (OS) was 11.3 months. Patients with locally advanced disease had longer median PFS (12.4 vs. 4.7 mo) and OS (15.7 vs. 6.4 mo) compared with patients with metastatic disease. The most common grade 3 to 4 toxicities included neutropenia (32%), infection (with normal or grade 1 to 2 neutropenia, in 24%), neuropathy (17%), fatigue (15%), and rash (7%). Five patients (12%) discontinued study treatment without evidence of progression. Rash was not a significant prognostic factor affecting PFS or OS. CONCLUSIONS: GOC is a feasible combination with an acceptable toxicity profile. However, GOC did not significantly extend PFS in the overall patient population to consider it for further development.

Original languageEnglish
Pages (from-to)446-450
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume35
Issue number5
DOIs
StatePublished - Oct 1 2012

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oxaliplatin
gemcitabine
Pancreatic Neoplasms
Disease-Free Survival
Exanthema
Neutropenia
Survival
Cetuximab
Fatigue

Keywords

  • cetuximab
  • clinical trial
  • gemcitabine
  • oxaliplatin
  • pancreatic cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Phase II study of gemcitabine, oxaliplatin, and cetuximab in advanced pancreatic cancer. / Merchan, Jaime R; Ferrell, Annaporna; MacIntyre, Jessica; Ciombor, Kristen K.; Levi, Joe; Ribeiro, Afonso; Sleeman, Danny; Flores, Aurea; Lopes, Gilberto; Rocha-Lima, Caio M.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 35, No. 5, 01.10.2012, p. 446-450.

Research output: Contribution to journalArticle

Merchan, Jaime R ; Ferrell, Annaporna ; MacIntyre, Jessica ; Ciombor, Kristen K. ; Levi, Joe ; Ribeiro, Afonso ; Sleeman, Danny ; Flores, Aurea ; Lopes, Gilberto ; Rocha-Lima, Caio M. / Phase II study of gemcitabine, oxaliplatin, and cetuximab in advanced pancreatic cancer. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2012 ; Vol. 35, No. 5. pp. 446-450.
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abstract = "OBJECTIVE: Little progress has been made in the treatment of pancreatic cancer (PC). This study evaluated the clinical activity of gemcitabine, oxaliplatin, and cetuximab (GOC) in patients with locally advanced or metastatic PC. METHODS: The study primary endpoint was progression-free survival (PFS). Eligible, chemotherapy-naive PC patients were treated with gemcitabine (1000 mg/m over 100 min) on day 1, oxaliplatin (100 mg/m) on day 2, every 2 weeks, and weekly cetuximab, (loading dose of 400 mg/m on cycle 1 day 1 and 250 mg/m thereafter). It was expected that GOC treatment would extend the median PFS from 5.8 to 7.54 months, a relative increase of 30{\%}, compared with gemcitabine and oxaliplatin (historical control). RESULTS: A total of 41 evaluable patients were enrolled. The overall response rate was 24{\%}. Median PFS time was 6.9 months and median overall survival (OS) was 11.3 months. Patients with locally advanced disease had longer median PFS (12.4 vs. 4.7 mo) and OS (15.7 vs. 6.4 mo) compared with patients with metastatic disease. The most common grade 3 to 4 toxicities included neutropenia (32{\%}), infection (with normal or grade 1 to 2 neutropenia, in 24{\%}), neuropathy (17{\%}), fatigue (15{\%}), and rash (7{\%}). Five patients (12{\%}) discontinued study treatment without evidence of progression. Rash was not a significant prognostic factor affecting PFS or OS. CONCLUSIONS: GOC is a feasible combination with an acceptable toxicity profile. However, GOC did not significantly extend PFS in the overall patient population to consider it for further development.",
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T1 - Phase II study of gemcitabine, oxaliplatin, and cetuximab in advanced pancreatic cancer

AU - Merchan, Jaime R

AU - Ferrell, Annaporna

AU - MacIntyre, Jessica

AU - Ciombor, Kristen K.

AU - Levi, Joe

AU - Ribeiro, Afonso

AU - Sleeman, Danny

AU - Flores, Aurea

AU - Lopes, Gilberto

AU - Rocha-Lima, Caio M.

PY - 2012/10/1

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N2 - OBJECTIVE: Little progress has been made in the treatment of pancreatic cancer (PC). This study evaluated the clinical activity of gemcitabine, oxaliplatin, and cetuximab (GOC) in patients with locally advanced or metastatic PC. METHODS: The study primary endpoint was progression-free survival (PFS). Eligible, chemotherapy-naive PC patients were treated with gemcitabine (1000 mg/m over 100 min) on day 1, oxaliplatin (100 mg/m) on day 2, every 2 weeks, and weekly cetuximab, (loading dose of 400 mg/m on cycle 1 day 1 and 250 mg/m thereafter). It was expected that GOC treatment would extend the median PFS from 5.8 to 7.54 months, a relative increase of 30%, compared with gemcitabine and oxaliplatin (historical control). RESULTS: A total of 41 evaluable patients were enrolled. The overall response rate was 24%. Median PFS time was 6.9 months and median overall survival (OS) was 11.3 months. Patients with locally advanced disease had longer median PFS (12.4 vs. 4.7 mo) and OS (15.7 vs. 6.4 mo) compared with patients with metastatic disease. The most common grade 3 to 4 toxicities included neutropenia (32%), infection (with normal or grade 1 to 2 neutropenia, in 24%), neuropathy (17%), fatigue (15%), and rash (7%). Five patients (12%) discontinued study treatment without evidence of progression. Rash was not a significant prognostic factor affecting PFS or OS. CONCLUSIONS: GOC is a feasible combination with an acceptable toxicity profile. However, GOC did not significantly extend PFS in the overall patient population to consider it for further development.

AB - OBJECTIVE: Little progress has been made in the treatment of pancreatic cancer (PC). This study evaluated the clinical activity of gemcitabine, oxaliplatin, and cetuximab (GOC) in patients with locally advanced or metastatic PC. METHODS: The study primary endpoint was progression-free survival (PFS). Eligible, chemotherapy-naive PC patients were treated with gemcitabine (1000 mg/m over 100 min) on day 1, oxaliplatin (100 mg/m) on day 2, every 2 weeks, and weekly cetuximab, (loading dose of 400 mg/m on cycle 1 day 1 and 250 mg/m thereafter). It was expected that GOC treatment would extend the median PFS from 5.8 to 7.54 months, a relative increase of 30%, compared with gemcitabine and oxaliplatin (historical control). RESULTS: A total of 41 evaluable patients were enrolled. The overall response rate was 24%. Median PFS time was 6.9 months and median overall survival (OS) was 11.3 months. Patients with locally advanced disease had longer median PFS (12.4 vs. 4.7 mo) and OS (15.7 vs. 6.4 mo) compared with patients with metastatic disease. The most common grade 3 to 4 toxicities included neutropenia (32%), infection (with normal or grade 1 to 2 neutropenia, in 24%), neuropathy (17%), fatigue (15%), and rash (7%). Five patients (12%) discontinued study treatment without evidence of progression. Rash was not a significant prognostic factor affecting PFS or OS. CONCLUSIONS: GOC is a feasible combination with an acceptable toxicity profile. However, GOC did not significantly extend PFS in the overall patient population to consider it for further development.

KW - cetuximab

KW - clinical trial

KW - gemcitabine

KW - oxaliplatin

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