A phase II study of biweekly pralatrexate and docetaxel in patients with advanced esophageal and gastroesophageal carcinoma that have failed first-line platinum-based therapy

Brian Petullo, Lai Wei, Melissa Yereb, Alison Neal, Jeffrey Rose, Tanios Bekaii-Saab, Christina Wu

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: The appropriate second-line therapy for patients with advanced gastroesophageal (GE) or esophageal (E) cancer after failure of first-line platinum-based therapy is unclear. Pralatrexate and docetaxel have independently been shown to have efficacy in the treatment of these cancers. Thus, we performed a clinical trial examining the efficacy of the combination of these agents in the treatment of GE and E cancer. Methods: A Fleming phase II design with a single stage of 32 patients was planned. Pralatrexate 120 mg/m2 and docetaxel 35 mg/m2 were administered on day 1 of 14-day cycles. The primary end-point was to evaluate the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and secondary end-points were to evaluate for progression-free survival (PFS) and overall survival (OS). Results: The study was halted prematurely due to loss of funding after the accrual of six patients. Two patients had stable disease (SD) and four patients had disease progression per RECIST. When applying PERCIST criteria in four evaluable patients, two had a partial response (PR) and two had SD. Median PFS was 1.9 months (95% CI, 0.8-7.2) and median OS was 5.5 (0.8-11.7) months. Conclusions: Pralatrexate and docetaxel as therapy in refractory esophageal and GE adenocarcinoma did not demonstrate meaningful preliminary activity. PERCIST may prove to better assess the meaningfulness of anatomic SD.

Original languageEnglish (US)
Pages (from-to)336-340
Number of pages5
JournalJournal of Gastrointestinal Oncology
Volume6
Issue number3
DOIs
StatePublished - Jan 1 2015
Externally publishedYes

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docetaxel
Platinum
Carcinoma
Disease-Free Survival
Therapeutics
Survival
Esophageal Neoplasms
Disease Progression
10-propargyl-10-deazaaminopterin
Neoplasms
Adenocarcinoma
Clinical Trials

Keywords

  • Docetaxel
  • Esophageal (E) cancer
  • Gastrointestinal neoplasms
  • Pralatrexate

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

Cite this

A phase II study of biweekly pralatrexate and docetaxel in patients with advanced esophageal and gastroesophageal carcinoma that have failed first-line platinum-based therapy. / Petullo, Brian; Wei, Lai; Yereb, Melissa; Neal, Alison; Rose, Jeffrey; Bekaii-Saab, Tanios; Wu, Christina.

In: Journal of Gastrointestinal Oncology, Vol. 6, No. 3, 01.01.2015, p. 336-340.

Research output: Contribution to journalArticle

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AU - Bekaii-Saab, Tanios

AU - Wu, Christina

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AB - Background: The appropriate second-line therapy for patients with advanced gastroesophageal (GE) or esophageal (E) cancer after failure of first-line platinum-based therapy is unclear. Pralatrexate and docetaxel have independently been shown to have efficacy in the treatment of these cancers. Thus, we performed a clinical trial examining the efficacy of the combination of these agents in the treatment of GE and E cancer. Methods: A Fleming phase II design with a single stage of 32 patients was planned. Pralatrexate 120 mg/m2 and docetaxel 35 mg/m2 were administered on day 1 of 14-day cycles. The primary end-point was to evaluate the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and secondary end-points were to evaluate for progression-free survival (PFS) and overall survival (OS). Results: The study was halted prematurely due to loss of funding after the accrual of six patients. Two patients had stable disease (SD) and four patients had disease progression per RECIST. When applying PERCIST criteria in four evaluable patients, two had a partial response (PR) and two had SD. Median PFS was 1.9 months (95% CI, 0.8-7.2) and median OS was 5.5 (0.8-11.7) months. Conclusions: Pralatrexate and docetaxel as therapy in refractory esophageal and GE adenocarcinoma did not demonstrate meaningful preliminary activity. PERCIST may prove to better assess the meaningfulness of anatomic SD.

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