Trial record 1 of 1 for:
NCT01178944
Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
This study is currently recruiting participants.
Verified March 2013 by Roswell Park Cancer Institute
Sponsor:
Roswell Park Cancer Institute
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01178944
First received: August 9, 2010
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
RATIONALE: 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 or by stopping them from dividing. Giving pralatrexate and oxaliplatin together may kill more tumor cells. PURPOSE: This phase II trial is studying how well pralatrexate and oxaliplatin work in treating patients with unresectable or metastatic esophageal, stomach, or gastroesophageal junction cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: pralatrexate Drug: oxaliplatin Other: pharmacogenomic studies Genetic: RNA analysis Genetic: polymorphism analysis Genetic: polymerase chain reaction Genetic: microarray analysis Procedure: esophagogastroduodenoscopy Procedure: biopsy Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pralatrexate in Combination With Oxaliplatin in Advanced Esophagogastric Cancer: A Phase II Trial With Predictive Molecular Correlates |
Resource links provided by NLM:
Further study details as provided by Roswell Park Cancer Institute:
Primary Outcome Measures:
- Overall response rate to combination pralatrexate and oxaliplatin as assessed by RECIST [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity as assessed by NCI CTCAE version 4.0 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Time to progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To examine whether functionally relevant polymorphisms of genes of the folate metabolism pathway correlate with efficacy and toxicity of pralatrexate. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To examine whether response to pralatrexate can be predicted by microRNA expression profiling of the epithelial component of the tumor. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 33 |
| Study Start Date: | September 2010 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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.
|
Drug: pralatrexate
Given IV
Other Names:
Drug: oxaliplatin
Given IV
Other Names:
Other: pharmacogenomic studies
Correlative studies
Other Name: Pharmacogenomic Study
Genetic: RNA analysis
Correlative studies
Genetic: polymorphism analysis
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Name: PCR
Genetic: microarray analysis
Correlative studies
Other Name: gene expression profiling
Procedure: esophagogastroduodenoscopy
Correlative studies
Other Name: EGD
Procedure: biopsy
Correlative studies
Other Name: biopsies
Other: laboratory biomarker analysis
Correlative studies
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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 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
- Nursing women are ineligible
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178944
Contacts
| Contact: AskRPCI | 877-275-7724 | AskRPCI@RoswellPark.org |
Locations
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Nikhil I. Khushalani 716-845-3099 nikhil.khushalani@roswellpark.org | |
| Principal Investigator: Nikhil I. Khushalani | |
Sponsors and Collaborators
Roswell Park Cancer Institute
National Comprehensive Cancer Network
Investigators
| Principal Investigator: | Nikhil Khushalani | Roswell Park Cancer Institute |
More Information
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01178944 History of Changes |
| Other Study ID Numbers: | I 169210, NCI-2010-01583 |
| Study First Received: | August 9, 2010 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Carcinoma, Squamous Cell Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Stomach Diseases Oxaliplatin Aminopterin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013