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

Completed · Phase 2

Conditions studied: Esophageal Cancer, Gastric Cancer

In brief

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.

Key facts

Study ID

NCT00985192

Run by

Translational Oncology Research International

People needed

49

Starts

2009-09-01

Expected to finish

2014-05-01

Last updated by the study team

2020-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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*
• 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

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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