A Phase 2 interventional study of everolimus and laboratory biomarker analysis in Esophageal Cancer and Gastric Cancer, sponsored by Translational Oncology Research International. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-05.
Sponsored by Translational Oncology Research International · Phase 2, Interventional, and Treatment
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with previously treated unresectable or metastatic esophageal cancer or stomach cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Blood, serum, and tumor tissue samples are collected for biomarker analysis.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 49 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Translational Oncology Research International is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
Drug: everolimus · Other: laboratory biomarker analysis
Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.
Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Time frame: Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.
Overall Survival
Overall Survival (OS), defined as the time from date of initial treatment to date of death. Survival function was estimated using the Kaplan-Meier method.
Time frame: 2.5 year
Efficacy in Terms of Progression Free Response
Progression-free survival (PFS), was defined as the time from the date of initial treatment to first objective documentation of disease progression, or death. Estimated using the Kaplan-Meier method. Complete response (CR) + partial response (PR) + stable disease (SD) were determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Radiologic disease assessments were utilized.
Time frame: evry 3 months in year 1, every 6 months after that
Observed Biomarkers
Potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in tumor tissue samples from these patients.
Time frame: 30 months
Biomarker Correlations: Progression Free Survival
Potential correlations between progression free survival and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.
Time frame: 30 months
Biomarker Correlations: Time to Progression
Potential correlations between time to progression and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.
Time frame: 30 months
| Milestone | Everolimus |
|---|---|
| Started | 49 |
| Completed | 45 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Disease progression | 1 |
| Withdrew: Determined to be ineligible during trial | 2 |
Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
| percent subjects with disease control | Everolimus |
|---|---|
| Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus. | 40 (23 to 54.8) |
Overall Survival (OS), defined as the time from date of initial treatment to date of death. Survival function was estimated using the Kaplan-Meier method.
| months | Everolimus |
|---|---|
| Overall Survival | 3.4 (2.7 to 5.6) |
Progression-free survival (PFS), was defined as the time from the date of initial treatment to first objective documentation of disease progression, or death. Estimated using the Kaplan-Meier method. Complete response (CR) + partial response (PR) + stable disease (SD) were determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Radiologic disease assessments were utilized.
| months | Everolimus |
|---|---|
| Efficacy in Terms of Progression Free Response | 1.8 (1.7 to 2.2) |
Potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in tumor tissue samples from these patients.
| number of tissue blocks | Everolimus |
|---|---|
| Tumor Grade 0, p-S6 | 4 |
| Tumor Grade 1+, p-S6 | 15 |
| Tumor Grade 2+, p-S6 | 8 |
| Tumor Grade 3+, p-S6 | 9 |
| Tumor Grade 4+, p-S6 | 3 |
| Tumor Grade 0, p-mTOR | 0 |
| Tumor Grade 1+, p-mTOR | 8 |
| Tumor Grade 2+, p-mTOR | 22 |
| Tumor Grade 3+, p-mTOR | 9 |
| Tumor Grade 4+, p-mTOR | 0 |
Potential correlations between progression free survival and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.
| months | Everolimus |
|---|---|
| p-S6 level 0-2 | 1.8 (1.6 to 1.9) |
| p-S6 level >2 | 3.5 (1.9 to 3.9) |
| p-mTOR level 0-2 | 1.8 (1.6 to 2.1) |
| p-mTOR level >2 | 2.6 (.7 to 3.9) |
Potential correlations between time to progression and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.
| months | Everolimus |
|---|---|
| p-S6 level 0-2 | 1.75 (1.6 to 1.8) |
| p-S6 level >2 | 3.4 (1.9 to 3.9) |
| p-mTOR level 0-2 | 1.8 (1.6 to 2.1) |
| p-mTOR level >2 | 2.6 (.7 to 3.9) |
Collected over Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Everolimus | — | 24/47 (51.1%) | 47/47 (100%) |
| Event | Everolimus |
|---|---|
| FatigueGeneral disorders | 9/47 |
| ThrombocytopeniaBlood and lymphatic system disorders | 9/47 |
| AnorexiaMetabolism and nutrition disorders | 5/47 |
| AnemiaBlood and lymphatic system disorders | 5/47 |
| MucositisMusculoskeletal and connective tissue disorders | 2/47 |
| HyperlipidemiaBlood and lymphatic system disorders | 2/47 |
| HyperglycemiaBlood and lymphatic system disorders | 1/47 |
| Event | Everolimus |
|---|---|
| FatigueGeneral disorders | 22/47 |
| ThrombocytopeniaBlood and lymphatic system disorders | 18/47 |
| AnemiaBlood and lymphatic system disorders | 17/47 |
| AnorexiaMetabolism and nutrition disorders | 14/47 |
| NauseaGastrointestinal disorders | 13/47 |
| DiarrheaGastrointestinal disorders | 11/47 |
| Mucositis - oral cavityMusculoskeletal and connective tissue disorders | 11/47 |
| RashSkin and subcutaneous tissue disorders | 11/47 |
| HypercholesteremiaBlood and lymphatic system disorders | 9/47 |
| Pain - abdomenNervous system disorders | 8/47 |
Of the 49 subjects enrolled, only 45 were determined to be evaluable due to subject withdrawal, an adverse event, and 2 subjects later determined to be ineligible. 45 is the analysis population
| Age, Continuous(years) | Everolimus |
|---|---|
| Median | 64 (38 to 82) |
| Sex: Female, Male(Participants) | Everolimus |
|---|---|
| Female | 8 |
| Male | 37 |
| Race/Ethnicity, Customized(participants) | Everolimus |
|---|---|
| White | 28 |
| Hispanic | 10 |
| Asian | 4 |
| Black | 3 |
| Region of Enrollment(participants) | Everolimus |
|---|---|
| United States | 45 |
| Disease Site(participants) | Everolimus |
|---|---|
| Gastric | 21 |
| Gastroesophageal Junction | 13 |
| Esophagus | 11 |
| Eastern Cooperative Oncology Group (ECOG) score(participants) | Everolimus |
|---|---|
| 0 | 15 |
| 1 | 30 |
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Translational Oncology Research International