Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
Completed · Phase 2
Conditions studied: Adenocarcinoma of the Gastroesophageal Junction, Esophageal Undifferentiated Carcinoma, Gastric Adenocarcinoma, Gastric Squamous Cell Carcinoma, Recurrent Esophageal Adenocarcinoma, Recurrent Esophageal Squamous Cell Carcinoma, Recurrent Gastric Carcinoma, Stage IIIB Esophageal Adenocarcinoma, Stage IIIB Esophageal Squamous Cell Carcinoma, Stage IIIB Gastric Cancer, Stage IIIC Esophageal Adenocarcinoma, Stage IIIC Esophageal Squamous Cell Carcinoma, Stage IIIC Gastric Cancer, Stage IV Esophageal Adenocarcinoma, Stage IV Esophageal Squamous Cell Carcinoma, Stage IV Gastric Cancer, Undifferentiated Gastric Carcinoma
In brief
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.
Key facts
- Study ID
- NCT01178944
- Run by
- Roswell Park Cancer Institute
- People needed
- 35
- Starts
- 2010-09-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2017-12-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 =< 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; nursing women are ineligible
- Written, informed consent
You may not qualify if…
- 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
Where it is running
- Roswell Park Cancer Institute — Buffalo, New York, United States
- Rochester General Hospital — Rochester, New York, United States
Full record on ClinicalTrials.gov
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