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Status:

COMPLETED

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

Lead Sponsor:

Translational Oncology Research International

Collaborating Sponsors:

National Cancer Institute (NCI)

University of California, Los Angeles

Conditions:

Esophageal Cancer

Gastric Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 w...

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 adenocarci...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2014

    Estimated Enrollment :

    49 Patients enrolled

    Trial Details

    Trial ID

    NCT00985192

    Start Date

    September 1 2009

    End Date

    May 1 2014

    Last Update

    August 5 2020

    Active Locations (18)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (18 locations)

    1

    Central Hematology Oncology Medical Group, Inc.

    Alhambra, California, United States, 91801

    2

    Comprehensive Blood and Cancer Center

    Bakersfield, California, United States, 93309

    3

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

    Fullerton, California, United States, 92835

    4

    Antelope Valley Cancer Center

    Lancaster, California, United States, 93534