Pemetrexed/oxaliplatin for first-line treatment of patients with advanced colorectal cancer

a phase II trial of the National Surgical Adjuvant Breast and Bowel Project Foundation Research Program.

James N. Atkins, Samuel A. Jacobs, H. Samuel Wieand, Roy E. Smith, William J. John, Linda H. Colangelo, Victor G. Vogel, J. Philip Kuebler, Terrence P. Cescon, Barbara J. Miller, Charles E. Geyer, Norman Wolmark

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

BACKGROUND: Pemetrexed and oxaliplatin have clinical activity as single agents in colorectal cancer (response rates, 10%-17%). In this study, these drugs were used in combination as first-line therapy in a group of patients with metastatic colorectal cancer. PATIENTS AND METHODS: Fifty-four evaluable patients were to receive pemetrexed (500 mg/m2) with folic acid and vitamin B12 supplementation and oxaliplatin (120 mg/m2) every 21 days for 6 cycles or until disease progression occurred. Patients with stable or responding disease could continue therapy beyond 6 cycles at the discretion of the investigator. Eligibility criteria included a diagnosis of untreated metastatic adenocarcinoma of the colon or rectum, measurable disease, Zubrod performance status <or=2, no adjuvant chemotherapy within 6 months, and >or=12 weeks life expectancy. RESULTS: The confirmed clinical response rate (primary endpoint) was 29.6% (95% confidence interval [CI], 18%-48.6%), with 1 complete response and 15 partial responses. Median time to progression was 5.3 months (95% CI, 3.9-6.3 months), and median survival was 12.3 months (95% CI, 8.6-17 months). Grade 3/4 nadir neutropenia occurred in 33.3% of patients, and 3 patients experienced grade 3 febrile neutropenia or infection associated with grade 3/4 neutropenia. Grade 3/4 nadir thrombocytopenia was seen in 11.1% of patients. Only 4% of the patients developed grade 3/4 neurotoxicity. CONCLUSION: This regimen of pemetrexed and oxaliplatin has activity in advanced colorectal cancer, and the toxicity profile suggests that escalation of the dose of pemetrexed in this combination may be possible.

Original languageEnglish (US)
Pages (from-to)181-187
Number of pages7
JournalClinical colorectal cancer.
Volume5
Issue number3
StatePublished - Sep 2005

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oxaliplatin
Pemetrexed
Colorectal Neoplasms
Breast
Research
Confidence Intervals
Neutropenia
Therapeutics
Febrile Neutropenia
Vitamin B 12
Life Expectancy
Folic Acid
Rectum
Disease Progression

ASJC Scopus subject areas

  • Oncology

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Pemetrexed/oxaliplatin for first-line treatment of patients with advanced colorectal cancer : a phase II trial of the National Surgical Adjuvant Breast and Bowel Project Foundation Research Program. / Atkins, James N.; Jacobs, Samuel A.; Wieand, H. Samuel; Smith, Roy E.; John, William J.; Colangelo, Linda H.; Vogel, Victor G.; Kuebler, J. Philip; Cescon, Terrence P.; Miller, Barbara J.; Geyer, Charles E.; Wolmark, Norman.

In: Clinical colorectal cancer., Vol. 5, No. 3, 09.2005, p. 181-187.

Research output: Contribution to journalArticle

Atkins, JN, Jacobs, SA, Wieand, HS, Smith, RE, John, WJ, Colangelo, LH, Vogel, VG, Kuebler, JP, Cescon, TP, Miller, BJ, Geyer, CE & Wolmark, N 2005, 'Pemetrexed/oxaliplatin for first-line treatment of patients with advanced colorectal cancer: a phase II trial of the National Surgical Adjuvant Breast and Bowel Project Foundation Research Program.', Clinical colorectal cancer., vol. 5, no. 3, pp. 181-187.
Atkins, James N. ; Jacobs, Samuel A. ; Wieand, H. Samuel ; Smith, Roy E. ; John, William J. ; Colangelo, Linda H. ; Vogel, Victor G. ; Kuebler, J. Philip ; Cescon, Terrence P. ; Miller, Barbara J. ; Geyer, Charles E. ; Wolmark, Norman. / Pemetrexed/oxaliplatin for first-line treatment of patients with advanced colorectal cancer : a phase II trial of the National Surgical Adjuvant Breast and Bowel Project Foundation Research Program. In: Clinical colorectal cancer. 2005 ; Vol. 5, No. 3. pp. 181-187.
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title = "Pemetrexed/oxaliplatin for first-line treatment of patients with advanced colorectal cancer: a phase II trial of the National Surgical Adjuvant Breast and Bowel Project Foundation Research Program.",
abstract = "BACKGROUND: Pemetrexed and oxaliplatin have clinical activity as single agents in colorectal cancer (response rates, 10{\%}-17{\%}). In this study, these drugs were used in combination as first-line therapy in a group of patients with metastatic colorectal cancer. PATIENTS AND METHODS: Fifty-four evaluable patients were to receive pemetrexed (500 mg/m2) with folic acid and vitamin B12 supplementation and oxaliplatin (120 mg/m2) every 21 days for 6 cycles or until disease progression occurred. Patients with stable or responding disease could continue therapy beyond 6 cycles at the discretion of the investigator. Eligibility criteria included a diagnosis of untreated metastatic adenocarcinoma of the colon or rectum, measurable disease, Zubrod performance status or=12 weeks life expectancy. RESULTS: The confirmed clinical response rate (primary endpoint) was 29.6{\%} (95{\%} confidence interval [CI], 18{\%}-48.6{\%}), with 1 complete response and 15 partial responses. Median time to progression was 5.3 months (95{\%} CI, 3.9-6.3 months), and median survival was 12.3 months (95{\%} CI, 8.6-17 months). Grade 3/4 nadir neutropenia occurred in 33.3{\%} of patients, and 3 patients experienced grade 3 febrile neutropenia or infection associated with grade 3/4 neutropenia. Grade 3/4 nadir thrombocytopenia was seen in 11.1{\%} of patients. Only 4{\%} of the patients developed grade 3/4 neurotoxicity. CONCLUSION: This regimen of pemetrexed and oxaliplatin has activity in advanced colorectal cancer, and the toxicity profile suggests that escalation of the dose of pemetrexed in this combination may be possible.",
author = "Atkins, {James N.} and Jacobs, {Samuel A.} and Wieand, {H. Samuel} and Smith, {Roy E.} and John, {William J.} and Colangelo, {Linda H.} and Vogel, {Victor G.} and Kuebler, {J. Philip} and Cescon, {Terrence P.} and Miller, {Barbara J.} and Geyer, {Charles E.} and Norman Wolmark",
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T1 - Pemetrexed/oxaliplatin for first-line treatment of patients with advanced colorectal cancer

T2 - a phase II trial of the National Surgical Adjuvant Breast and Bowel Project Foundation Research Program.

AU - Atkins, James N.

AU - Jacobs, Samuel A.

AU - Wieand, H. Samuel

AU - Smith, Roy E.

AU - John, William J.

AU - Colangelo, Linda H.

AU - Vogel, Victor G.

AU - Kuebler, J. Philip

AU - Cescon, Terrence P.

AU - Miller, Barbara J.

AU - Geyer, Charles E.

AU - Wolmark, Norman

PY - 2005/9

Y1 - 2005/9

N2 - BACKGROUND: Pemetrexed and oxaliplatin have clinical activity as single agents in colorectal cancer (response rates, 10%-17%). In this study, these drugs were used in combination as first-line therapy in a group of patients with metastatic colorectal cancer. PATIENTS AND METHODS: Fifty-four evaluable patients were to receive pemetrexed (500 mg/m2) with folic acid and vitamin B12 supplementation and oxaliplatin (120 mg/m2) every 21 days for 6 cycles or until disease progression occurred. Patients with stable or responding disease could continue therapy beyond 6 cycles at the discretion of the investigator. Eligibility criteria included a diagnosis of untreated metastatic adenocarcinoma of the colon or rectum, measurable disease, Zubrod performance status or=12 weeks life expectancy. RESULTS: The confirmed clinical response rate (primary endpoint) was 29.6% (95% confidence interval [CI], 18%-48.6%), with 1 complete response and 15 partial responses. Median time to progression was 5.3 months (95% CI, 3.9-6.3 months), and median survival was 12.3 months (95% CI, 8.6-17 months). Grade 3/4 nadir neutropenia occurred in 33.3% of patients, and 3 patients experienced grade 3 febrile neutropenia or infection associated with grade 3/4 neutropenia. Grade 3/4 nadir thrombocytopenia was seen in 11.1% of patients. Only 4% of the patients developed grade 3/4 neurotoxicity. CONCLUSION: This regimen of pemetrexed and oxaliplatin has activity in advanced colorectal cancer, and the toxicity profile suggests that escalation of the dose of pemetrexed in this combination may be possible.

AB - BACKGROUND: Pemetrexed and oxaliplatin have clinical activity as single agents in colorectal cancer (response rates, 10%-17%). In this study, these drugs were used in combination as first-line therapy in a group of patients with metastatic colorectal cancer. PATIENTS AND METHODS: Fifty-four evaluable patients were to receive pemetrexed (500 mg/m2) with folic acid and vitamin B12 supplementation and oxaliplatin (120 mg/m2) every 21 days for 6 cycles or until disease progression occurred. Patients with stable or responding disease could continue therapy beyond 6 cycles at the discretion of the investigator. Eligibility criteria included a diagnosis of untreated metastatic adenocarcinoma of the colon or rectum, measurable disease, Zubrod performance status or=12 weeks life expectancy. RESULTS: The confirmed clinical response rate (primary endpoint) was 29.6% (95% confidence interval [CI], 18%-48.6%), with 1 complete response and 15 partial responses. Median time to progression was 5.3 months (95% CI, 3.9-6.3 months), and median survival was 12.3 months (95% CI, 8.6-17 months). Grade 3/4 nadir neutropenia occurred in 33.3% of patients, and 3 patients experienced grade 3 febrile neutropenia or infection associated with grade 3/4 neutropenia. Grade 3/4 nadir thrombocytopenia was seen in 11.1% of patients. Only 4% of the patients developed grade 3/4 neurotoxicity. CONCLUSION: This regimen of pemetrexed and oxaliplatin has activity in advanced colorectal cancer, and the toxicity profile suggests that escalation of the dose of pemetrexed in this combination may be possible.

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