Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer

NCT00985192 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000655574UCLA-TRIO-TORI-GI-06IRB# 09-07-061-01NOVARTIS-UCLA-TRIO-TORI-GI-06
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Esophageal Cancer; Gastric Cancer

Keywords

adenocarcinoma of the esophagus; adenocarcinoma of the stomach; recurrent esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer; recurrent gastric cancer; stage III gastric cancer; stage IV gastric cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.

Secondary Outcomes (5)

• Overall Survival

  2.5 year

• Efficacy in Terms of Progression Free Response

  evry 3 months in year 1, every 6 months after that

• Observed Biomarkers

  30 months

• Biomarker Correlations: Progression Free Survival

  30 months

• Biomarker Correlations: Time to Progression

  30 months

Study Arms (1)

Everolimus

EXPERIMENTAL

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

Interventions

everolimus DRUG

Everolimus

laboratory biomarker analysis OTHER

Everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of adenocarcinoma of the upper gastrointestinal tract
• Metastatic or unresectable disease
• Received 1-2 prior chemotherapy or biological therapy regimens for unresectable or metastatic disease
• Measurable disease in ≥ 1 dimension by CT scan or MRI
• Patients whose only measurable lesion is a metastatic lymph node are eligible provided they have permission from the principal investigator
• ECOG performance status 0-1
• Life expectancy \> 3 months
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN if there is liver metastasis)
• Creatinine clearance \> 60 mL/min
• Fasting serum cholesterol \< 300 mg/dL or \< 7.75 mmol/L\*
• Fasting triglycerides \< 2.5 times ULN\*

You may not qualify if:

• uncontrolled diabetes mellitus, defined as fasting serum glucose \> 1.5 times ULN
• severely impaired lung function
• known HV infection
• active, bleeding diathesis
• unstable angina pectoris, symptomatic congestive heart failure, or myocardial infarction within the past 6 months
• serious uncontrolled cardiac arrhythmia
• active or uncontrolled infection requiring parenteral antimicrobials
• known liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent hepatitis)
• inability to swallow, impaired gastrointestinal (GI) function, or GI disease (e.g., ulcerative colitis, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) that would significantly alter the absorption of study drugs or preclude the use of oral medications
• other malignancy within the past 5 years except for nonmelanoma skin cancer or cervical carcinoma in situ
• known hypersensitivity to everolimus, sirolimus, or temsirolimus or to their excipients
• other medical conditions that, in the opinion of the investigator, would preclude study participation
• prior mTOR inhibitors (e.g., rapamycin, CCI-779)
• concurrent chronic treatment with steroids or another immunosuppressive agent
• concurrent prophylactic use of hematopoietic growth factors

Sponsors & Collaborators

• Translational Oncology Research International: lead
• National Cancer Institute (NCI): collaborator
• University of California, Los Angeles: collaborator

Study Sites (18)

Central Hematology Oncology Medical Group, Inc.

Alhambra, California, 91801, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center

Fullerton, California, 92835, United States

Location

Antelope Valley Cancer Center

Lancaster, California, 93534, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Translational Oncology Research International (TORI) Network

Los Angeles, California, 90095, United States

Location

North Valley Hematology/Oncology Medical Group

Northridge, California, 91328, United States

Location

Wilshire Oncology Medical Group, Inc.

Pomona, California, 91767, United States

Location

Cancer Care Associates Medical Group, Inc.

Redondo Beach, California, 90277, United States

Location

TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.)

Redondo Beach, California, 90277, United States

Location

Sansum Medical Clinic

Santa Barbara, California, 93105, United States

Location

Santa Barbara Hematology Oncology Medical Group, Inc.

Santa Barbara, California, 93105, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

Trivalley Oncology Hematology

Westlake Village, California, 91361, United States

Location

Suburban Hematology-Oncology Associates, P.A.

Lawrenceville, Georgia, 30045, United States

Location

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, 30060, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89109, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Limitations and Caveats

This study had several limitations with the major weakness being that it was a single- rm, non-comparative study. At the time this study was launched, a Japanese report indicating a DCR was 50 % was not yet reported.

Results Point of Contact

• Title: Dr. Zev Wainberg
• Organization: UCLA GI Oncology Program, David Geffen School of Medicine at UCLA

zwainberg@mednet.ucla.edu

310 794-6500

Study Officials

• Zev A. Wainberg, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 5, 2020
• Results First Posted: March 29, 2016

Record last verified: 2016-02

Locations

US (18)