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Pralatrexate in Combination With Oxaliplatin in Advanced Esophagogastric Cancer: A Phase II Trial With Predictive Molecular Correlates

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Recurrent Esophageal Cancer, Recurrent Gastric Cancer, Squamous Cell Carcinoma of the Esophagus, Stage III Esophageal Cancer, Stage III Gastric Cancer, Stage IV Esophageal Cancer, Stage IV Gastric Cancer

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Trial Information

Pralatrexate in Combination With Oxaliplatin in Advanced Esophagogastric Cancer: A Phase II Trial With Predictive Molecular Correlates

PRIMARY OBJECTIVES: I. To determine the overall response rate in patients with advanced
esophago-gastric cancer to combination pralatrexate and oxaliplatin. SECONDARY OBJECTIVES:
I. To examine the toxicity and tolerability of this regimen. II. To determine the
time-to-progression and overall survival using this regimen. III. To examine whether
functionally relevant polymorphisms of genes of the folate metabolism pathway correlate with
efficacy and toxicity of pralatrexate. IV. To examine whether response to pralatrexate can
be predicted by microRNA expression profiling of the epithelial component of the tumor.
OUTLINE: Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours
on day 1. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease
progression or unacceptable toxicity. After completion of study treatment, patients are
followed up for 30 days and then periodically thereafter for up to 5 years.

Inclusion Criteria:

- Histologically confirmed carcinoma of the esophagus, stomach or gastro-esophageal
junction that is metastatic, or locally advanced and inoperable for cure;
histological sub-types permitted included adenocarcinoma, squamous-cell carcinoma, or
undifferentiated carcinoma (small-cell carcinoma variant is not eligible)

- No previous systemic therapy for metastatic or recurrent disease; therapy
(chemotherapy, radiotherapy, or both) administered in the neo-adjuvant, adjuvant, or
definitive setting for previously localized disease is permitted, provided it was
completed more than 6 months prior to enrollment; palliative radiotherapy is
permitted provided it is completed >= 3 weeks prior to study therapy initiation

- ECOG performance status 0-2

- Life expectancy >= 12 weeks

- Hemoglobin >= 9 g/dl

- Absolute neutrophil count >= 1500/mm^3

- Platelet count >= 100,000/mm^3

- Serum creatinine =< institutional upper limit normal (ULN)

- Bilirubin =< 1.5 x ULN

- Transaminases =< 3 x ULN; for documented liver metastases (transaminases up to 5 x
ULN is permitted)

- No evidence of >= grade 2 peripheral neuropathy

- Patients with reproductive potential must be willing to use an adequate contraceptive
method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device
with spermicide or surgical sterilization) during treatment and for three months
after completing treatment; a negative pregnancy test is required for women of
child-bearing potential

- Written, informed consent

Exclusion Criteria:

- Hypersensitivity to platinum compounds

- Uncontrolled inter-current illness including but not limited to active infection,
symptomatic congestive heart failure, unstable angina, uncontrolled cardiac
arrhythmia, or psychiatric illness that would limit compliance with study

- Presence of brain metastases

- Patients with third-space (pleural, peritoneal) fluid not controllable with usual
drainage methods are not eligible

- History of second primary malignancy within 3 years prior to enrollment, except for
in-situ cervix carcinoma or non-melanoma skin cancer

- Undergone an allogeneic stem cell transplant

- Nursing women are ineligible

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate to combination pralatrexate and oxaliplatin as assessed by RECIST

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Nikhil Khushalani

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Institutional Review Board

Study ID:

I 169210



Start Date:

September 2010

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Esophagus
  • Adenocarcinoma of the Gastroesophageal Junction
  • Diffuse Adenocarcinoma of the Stomach
  • Intestinal Adenocarcinoma of the Stomach
  • Mixed Adenocarcinoma of the Stomach
  • Recurrent Esophageal Cancer
  • Recurrent Gastric Cancer
  • Squamous Cell Carcinoma of the Esophagus
  • Stage III Esophageal Cancer
  • Stage III Gastric Cancer
  • Stage IV Esophageal Cancer
  • Stage IV Gastric Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263