Gastric Adenocarcinoma Clinical Trial
Official title:
Pralatrexate in Combination With Oxaliplatin in Advanced Esophago-gastric Cancer: A Phase II Trial With Predictive Molecular Correlates
Verified date | November 2017 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | November 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 =< 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 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 |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Rochester General Hospital | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | National Cancer Institute (NCI), National Comprehensive Cancer Network |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes | Kaplan-Meier estimates of median survival time for each genotype | From the date of study enrollment up to 5 years | |
Other | MicroRNA Expression - miR-215-5p | Mean microRNAs expression of mi-215-5p in tumor tissues of responders and non-responders using a microfabricated device called a gene chip. | Baseline | |
Primary | Overall Response Rate | Overall response rate to combination pralatrexate and oxaliplatin as assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Objective responses will be confirmed 4 weeks after first documentation of response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 5 years | |
Secondary | Number of Participants With an Adverse Event | Number of participants with an adverse event. Please refer to the adverse event reporting for more detail. Incidence of toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 | Up to 30 days after the last dose of study drug(s) | |
Secondary | Overall Survival (OS) | Estimated using the Kaplan-Meier method and proportional hazards models. | From the date of study enrollment to the time of death from any cause, assessed up to 5 years | |
Secondary | Time to Progression (TTP) | Estimated using the Kaplan-Meier method and proportional hazards models. | From the date of study enrollment to the first observation of progressive disease, assessed up to 5 years |
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