Status:
TERMINATED
RAD001 and Erlotinib in Patients With Neuroendocrine Tumors
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Genentech, Inc.
Novartis Pharmaceuticals
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test how safe and effective the combination of RAD001 and erlotinib is in patients with neuroendocrine tumors.
Detailed Description
Preclinical data suggest that concomitant inhibition of two non-redundant amplified pathways (mTOR and EGFR) can reverse drug resistance and more profoundly affect tumor growth than targeting either p...
Eligibility Criteria
Inclusion
- \>=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
Exclusion
- 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
Key Trial Info
Start Date :
June 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00843531
Start Date
June 25 2009
End Date
August 20 2016
Last Update
September 29 2020
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94115