Everolimus and Combination Chemotherapy in Treating Patients With Metastatic Stomach or Esophageal Cancer

Completed · Phase 1/Phase 2

Conditions studied: Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Recurrent Esophageal Cancer, Recurrent Gastric Cancer, Stage IV Esophageal Cancer, Stage IV Gastric Cancer

In brief

RATIONALE: Everolimus may stop the growth of stomach or esophageal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Giving everolimus together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with combination chemotherapy in treating patients with metastatic stomach or esophageal cancer that has spread to other places in the body.

Key facts

Study ID: NCT01231399
Run by: City of Hope Medical Center
People needed: 6
Starts: 2012-02-01
Expected to finish: 2016-07-01
Last updated by the study team: 2017-05-31

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically confirmed diagnosis of gastric, esophageal, and GEJ adenocarcinoma
Patients must have metastatic disease
Patients must not have received any chemotherapy for metastatic disease
Patients may have received prior adjuvant chemotherapy; completion of chemotherapy must be greater than 6 months from date of recurrent disease
Patients must have computed tomography (CT) or magnetic resonance imaging (MRI) scan; patients must have at least one measurable site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria that has not been previously irradiated; if the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation
Patients must have a ECOG Performance Status of 0-1
Absolute neutrophil count (ANC) > 1,500/mcl
Platelet count > 100,000/mcl
Hemoglobin (Hg) > 9 g/dL
Serum creatinine < 1.5 mg/dl and/or Creatinine clearance > 60 cc/min
Bilirubin < 1.5 mg/dl
Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamic pyruvic transaminase (SGPT) =< 2.5 x institutional upper limit of normal (IULN) (=< 5 x upper limit of normal [ULN] in patients with liver metastases)
Fasting serum cholesterol =< 300 mg/dL or =< 7.75 mmol/L
Fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Patients should have controlled diabetes as evidenced by hemoglobin (Hb)A1C =< 8%
International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5; (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at time of randomization)
Due to the possibility of harm to a fetus or nursing infant from this treatment regimen, patients must not be pregnant or nursing (or plan to become pregnant); women and men of reproductive potential must have agreed to use a highly effective contraceptive method for at least 8 weeks after treatment
Patients with risk factors for contraction hepatitis B or C should undergo screening prior to treatment on protocol. Patients with detectable viral titers are required to receive treatment for 4 weeks prior to starting protocol therapy.
Patients must be able to swallow pills
No other prior malignancy within the past 3 years is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must have pathology specimen available for submission

You may not qualify if…

Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc)
Patients who have received prior treatment with an mammalian target of rapamycin (mTOR) inhibitor (sirolimus, temsirolimus, everolimus)
Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients
Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
Prior treatment with any investigational drug within the preceding 4 weeks
Patients receiving chronic, systemic treatment with corticosteroids (prednisone > 10 mg per day) or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
Symptomatic congestive heart failure of New York heart Association Class III or IV
Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
Severely impaired lung function as defined as spirometry and diffusion lung capacity of carbon monoxide (DLCO) that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN
Active (acute or chronic) or uncontrolled severe infections
Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
A known history of human immunodeficiency virus (HIV) seropositivity
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
Patients with an active, bleeding diathesis; history of noncompliance to medical regimens
Patients unwilling to or unable to comply with the protocol

Where it is running

City of Hope Medical Center — Duarte, California, United States
South Pasadena Cancer Center — South Pasadena, California, United States
H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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