Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Can… (NCT00985192) | Clinical Trial Compass
CompletedPhase 2
Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer
United States49 participantsStarted 2009-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
What they're measuring
1
Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.
Timeframe: Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.
Trial details
NCT IDNCT00985192
SponsorTranslational Oncology Research International