Phase 2 N=35 Treatment

Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer

Adenocarcinoma of the Gastroesophageal Junction · Esophageal Undifferentiated Carcinoma · Gastric Adenocarcinoma · Gastric Squamous Cell Carcinoma · Recurrent Esophageal Adenocarcinoma

Bottom Line

View on ClinicalTrials.gov: NCT01178944 ↗

Enrolled (actual)

Serious AEs

28.6%

Results posted

Dec 2017

Primary outcome: Primary: Overall Response Rate — 26 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Laboratory Biomarker Analysis (Other); Oxaliplatin (Drug); Pralatrexate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Roswell Park Cancer Institute
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Response Rate	26	—
SECONDARY Number of Participants With an Adverse Event	35	—
SECONDARY Overall Survival (OS)	7.2	—
SECONDARY Time to Progression (TTP)	5.1	—

Summary

This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by surgery or has spread from the primary site (place where it started) to other places in the body. Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pralatrexate with oxaliplatin may be an effective treatment for esophageal, stomach, or gastroesophageal junction cancer.

Eligibility Criteria

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 include 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
Eastern Cooperative Oncology Group (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 = = 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; nursing women are ineligible
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 requirements
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01178944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.