Everolimus and Combination Chemotherapy in Treating Patients With Metastatic Stomach or Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT01231399|
Recruitment Status : Completed
First Posted : November 1, 2010
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
RATIONALE: Everolimus may stop the growth of stomach or esophageal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Giving everolimus together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with combination chemotherapy in treating patients with metastatic stomach or esophageal cancer that has spread to other places in the body.
|Condition or disease||Intervention/treatment||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 Stage IV Esophageal Cancer Stage IV Gastric Cancer||Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Drug: everolimus Other: laboratory biomarker analysis Other: immunohistochemistry staining method Genetic: microarray analysis||Phase 1 Phase 2|
I. To determine the maximum tolerated dose of everolimus to use in combination with mFOLFOX6 [oxaliplatin, leucovorin (leucovorin calcium), 5-FU (fluorouracil)].
II. To better describe the toxicities associated with the combination of everolimus with mFOLFOX6.
III. To assess response rate and progression-free survival in this patient population.
IV. To assess overall survival in patients with metastatic gastric, esophageal and gastroesophageal junction (GEJ) adenocarcinoma treated with the combination of mFOLFOX6 + everolimus.
OUTLINE: This is a dose-escalation study of everolimus. Patients receive fluorouracil intravenously (IV) continuously over 46 hours, leucovorin calcium IV over 2 hours, and oxaliplatin IV over 2 hours on day 1. Patients also receive oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Trial of mFOLFOX6 and Everolimus (NSC-733504) in Patients With Metastatic Gastroesophageal Adenocarcinoma|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Arm I
Patients receive fluorouracil IV continuously over 46 hours, leucovorin calcium IV over 2 hours, and oxaliplatin IV over 2 hours on day 1. Patients also receive oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: leucovorin calcium
Other: laboratory biomarker analysis
Other: immunohistochemistry staining method
Other Name: immunohistochemistry
Genetic: microarray analysis
Other Name: gene expression profiling
- Maximum Tolerated Dose (MTD) of Everolimus [ Time Frame: Course 1 (first 28 days) ]The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
- Number of Subject With Overall Response [ Time Frame: Up to 5 years ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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
- Progression-free Survival [ Time Frame: up to 5 years ]Estimated using the product-limit method of Kaplan and Meier. From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Overall Survival [ Time Frame: Up to 5 years. ]Estimated using the product-limit method of Kaplan and Meier. From the date treatment started until the date of death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231399
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|South Pasadena Cancer Center|
|South Pasadena, California, United States, 91030|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Vincent Chung||City of Hope Medical Center|