RAD001 and Erlotinib in Patients With Neuroendocrine Tumors

Stopped early · Phase 2

Conditions studied: Neuroendocrine Tumors

In brief

The purpose of this study is to test how safe and effective the combination of RAD001 and erlotinib is in patients with neuroendocrine tumors.

Key facts

Study ID

NCT00843531

Run by

University of California, San Francisco

People needed

17

Starts

2009-06-25

Expected to finish

2016-08-20

Last updated by the study team

2020-09-29

Who can join

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

You may qualify if…

• >=1 measurable disease site per RECIST, not previously irradiated (if previous radiation to marker lesion(s), need evidence of PD)
• Histologic dx of well- to moderately-differentiated NET: low- or intermediate-grade, islet cell carcinoma, pancreatic NET, carcinoid, atypical carcinoid, paraganglioma, pheochromocytoma. No longer enrolling carcinoid patients as of 4/25/2011.
• ≥4 wks since completion of prior investigational drug tx or other tx(radiation, chemotherapy, immunotherapy, antibody-based tx); recovery from acute toxicities of prior tx
• Eastern Cooperative Oncology Group (ECOG) ≤2
• Absolute Neutrophil Count (ANC) ≥1500/μL
• Plts ≥100,000/μL
• Hgb >9 gm/dL
• Total bilirubin ≤2.0 mg/dL or 1.5X upper limit of normal (ULN)
• Serum transaminases ≤2.5x ULN (≤5xULN if liver mets)
• Serum Cr ≤2.0 mg/dL or 1.5X ULN
• Fasting serum glucose <150 mg/dL or <1.5x ULN
• Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤2.5xULN
• International Normalized Ratio (INR) ≤1.5
• Written informed consent, compliance w/study requirements
• Archived tissue if available
• Negative urine/serum pregnancy test w/in 7 days prior to Day 1

You may not qualify if…

• Poorly differentiated NET, high-grade NET, adenocarcinoid, goblet cell carcinoid, small cell carcinoma
• Major surgery or traumatic injury w/in 4 wks, inadequate recovery from side effects of any surgery, or likely to require major surgery during study
• Liver-directed therapy w/in 2 mths of enrollment. Prior tx w/ radiotherapy (including radiolabeled spheres, cyberknife, hepatic arterial embolization (w/ or w/o chemotherapy), cryotherapy/ablation) allowed if areas of measurable disease being used for the study are not affected, or if PD can clearly be documented in the area
• Prior tx w/ EGFR inhibitor or mTOR inhibitor
• Known hypersensitivity to RAD001 or other rapamycins
• Chronic, systemic tx w/ corticosteroids or another immunosuppressive agent (topical or inhaled corticosteroids are allowed)
• Immunization w/ attenuated live vaccines w/in 1 wk of study entry or during study
• Uncontrolled brain or leptomeningeal mets, including pts who continue to require glucocorticoids for brain or leptomeningeal mets
• Other malignancies w/in the past 3 years except for adequately treated carcinoma of the cervix, basal/squamous cell skin carcinomas, or other in situ cancer
• Severe and/or uncontrolled intercurrent medical conditions or other conditions that may affect study participation, including, but not limited to:
• Severely impaired lung function (spirometry and Diffusing capacity of the lungs for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or O2 saturation ≤88% at rest on room air)
• Symptomatic congestive heart failure (CHF) of New York Heart Association (NYHA) Class III or IV
• Unstable angina pectoris, symptomatic CHF, myocardial infarction w/in 6 months of Day 1, uncontrolled cardiac arrhythmia or any other significant cardiac disease
• Uncontrolled diabetes (fasting serum glucose ≥ 150 mg/dL or >1.5x upper limit of normal (ULN))
• Any active (acute or chronic) or severe infection, disorder, or nonmalignant medical illness that is uncontrolled or whose control may be jeopardized by study tx
• Liver disease
• Hx of HIV seropositivity or other immunocompromised state
• GI function impairment or disease that may alter absorption of RAD001 or erlotinib
• Active, bleeding diathesis or on oral anti-vitamin K medication (patients needing anticoagulation must use low molecular weight heparin (LMWH))
• Hx of other disease, metabolic dysfunction, or physical exam or lab finding giving reasonable suspicion of disease/condition that contraindicates study tx, might affect study results or puts the pt at high risk
• Pregnant or breast feeding females
• Adults of reproductive potential not willing to use effective methods of birth control during tx and ≥8 wks after completing tx
• Inability to comply w/ objectives and procedures
• Inability to comply w/ concomitant medication restrictions

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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