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

NCT ID: NCT00985192

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-05-31

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.

Detailed Description

OBJECTIVES:

Primary

• To determine the overall disease-control rate (complete response, partial response, or stable disease) in patients with previously treated unresectable or metastatic adenocarcinoma of the upper gastrointestinal tract treated with everolimus.

Secondary

• To determine the safety and toxicity of everolimus in these patients.
• To determine the efficacy of everolimus, in terms of time to response, duration of response, time to tumor progression, progression-free survival, and overall survival, in these patients.
• To explore potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in blood and tumor biopsy samples from these patients.

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.

Conditions

Esophageal Cancer; Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everolimus

Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity

Group Type: EXPERIMENTAL

everolimus

Intervention Type: DRUG

laboratory biomarker analysis

Intervention Type: OTHER

Interventions

everolimus

Intervention Type: DRUG

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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*
• INR ≤ 3.5 (for patients on warfarin)
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 4 months after completion of study treatment (oral, implantable, or injectable contraceptives are not considered effective contraception for this study)
• More than 30 days since prior chemotherapy, surgery, radiotherapy, or investigational agents

Exclusion Criteria

• 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
• concurrent anticancer agents or therapy (including radiotherapy)
• other concurrent experimental agents
• concurrent strong inhibitors or inducers of the isoenzyme CYP3A4

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Translational Oncology Research International

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zev A. Wainberg, MD

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Central Hematology Oncology Medical Group, Inc.

Alhambra, California, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

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

Fullerton, California, United States

Antelope Valley Cancer Center

Lancaster, California, United States

Pacific Shores Medical Group

Long Beach, California, United States

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Translational Oncology Research International (TORI) Network

Los Angeles, California, United States

North Valley Hematology/Oncology Medical Group

Northridge, California, United States

Wilshire Oncology Medical Group, Inc.

Pomona, California, United States

Cancer Care Associates Medical Group, Inc.

Redondo Beach, California, United States

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

Redondo Beach, California, United States

Sansum Medical Clinic

Santa Barbara, California, United States

Santa Barbara Hematology Oncology Medical Group, Inc.

Santa Barbara, California, United States

Central Coast Medical Oncology Corporation

Santa Maria, California, United States

Trivalley Oncology Hematology

Westlake Village, California, United States

Suburban Hematology-Oncology Associates, P.A.

Lawrenceville, Georgia, United States

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

UCLA-TRIO-TORI-GI-06

Identifier Type: -

Identifier Source: secondary_id

IRB# 09-07-061-01

Identifier Type: -

Identifier Source: secondary_id

NOVARTIS-UCLA-TRIO-TORI-GI-06

Identifier Type: -

Identifier Source: secondary_id

CDR0000655574

Identifier Type: -

Identifier Source: org_study_id