- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374140
Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer
September 18, 2017 updated by: Ahmad Tarhini
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer.
RAD001 will be administered orally at a dose of 10 mg daily.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer.
Patients may have received up to 2 prior chemotherapy regimens for small cell lung carcinoma, but no prior therapy with an m-TOR inhibitor.
RAD001 will be administered orally at a dose of 10 mg daily.
A cycle will be defined as 3 weeks of study drug administration, and patients will have tumor measurements every 2 cycles.
Study participation will continue until disease progression or intolerable toxicities.
In addition, in patients who consent, archival tumor tissue (paraffin block from original biopsy) will be collected for research purposes.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Steubenville, Ohio, United States, 43952
- UPMC Cancer Center - Teramana Cancer Center - Steubenville
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Pennsylvania
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Beaver, Pennsylvania, United States, 15009
- UPMC Cancer Center - Beaver
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Clairton, Pennsylvania, United States, 15025
- UPMC Cancer Center - Clairton
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Greensburg, Pennsylvania, United States, 15601
- UPMC Cancer Center - Arnold Palmer Pavilion - Greensburg
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Greensburg, Pennsylvania, United States, 15601
- UPMC Cancer Center - Oakbrook Commons - Greensburg
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Indiana, Pennsylvania, United States, 15701
- UPMC Cancer Center - Indiana
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Johnstown, Pennsylvania, United States, 15901
- UPMC Cancer Center - John P. Murtha Pavilion - Johnstown
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McKeesport, Pennsylvania, United States, 15132
- UPMC Cancer Center - McKeesport
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Monroeville, Pennsylvania, United States, 15146
- UPMC Cancer Center - Monroeville
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Moon, Pennsylvania, United States, 15108
- UPMC Cancer Center - Sewickley Medical Oncology/Hematology Group
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New Castle, Pennsylvania, United States, 16105
- UPMC Cancer Center - New Castle
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Cancer Institute - Hillman Cancer Center
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Pittsburgh, Pennsylvania, United States, 15215
- UPMC Cancer Center - St. Margaret's
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Pittsburgh, Pennsylvania, United States, 15237
- UPMC Cancer Center - Passavant
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Pittsburgh, Pennsylvania, United States, 15241
- UPMC Cancer Center - Upper St. Clair
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Pittsburgh, Pennsylvania, United States, 15219
- UPMC Cancer Center - Mercy
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Uniontown, Pennsylvania, United States, 15401
- UPMC Cancer Center - Uniontown
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Washington, Pennsylvania, United States, 15301
- UPMC Cancer Center - Washington
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Wexford, Pennsylvania, United States, 15090
- UPMC Cancer Center - North Hills
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cytologically or histologically confirmed small cell carcinoma of the lung that has progressed post first-line therapy. Mixed small and non-small cell tumors are excluded.
- Prior chemotherapy for small cell carcinoma. Up to 2 prior chemotherapy regimens for small cell lung carcinoma are allowed. No prior therapy with an m-TOR inhibitor (e.g. CCI-779).
- Unidimensionally measurable disease (RECIST criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area.
- ECOG performance status 0-2.
- A minimum of 4 weeks should elapse from prior chemotherapy. Patients must have fully recovered from the effects of any prior surgery or radiation therapy or other anticancer therapies, including immunotherapy and investigational agents.
- No progressive brain metastases. Brain metastases should have been previously treated with surgery and/or radiation.
- Patients with a prior malignancy should have at least 3 years of disease-free survival. Prior curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer or other in situ malignancies are allowed.
- No other coexisting medical condition that would preclude full compliance with the study.
Required laboratory values (obtained < 1 week prior to enrollment):
- ANC >/= 1500/mm³
- Platelets >/= 100,000/mm³
- AST and ALT ≤ 3 x ULN (upper limits of normal). In patients with liver metastases AST and ALT should be < 5 x ULN.
- Total bilirubin up to 1.5 x ULN (upper limits of normal).
- Age >/= 18 years and capacity to give informed consent.
- Patients should be advised to discontinue drugs that interact with CYP3A4 (see list of examples in Table 3.1 of the full protocol), if medically safe.
- All patients must have given signed, informed consent prior to registration on study.
Exclusion Criteria:
- Prior treatment with any investigational agent within the preceding 4 weeks.
- Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration).
- A known history of HIV seropositivity.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
- Patients with an active, bleeding diathesis or on anticoagulation (except low dose warfarin).
- Pregnant and lactating women are excluded from the study because the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk.
- Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study.
- Patients should not be on chronic systemic glucocorticoids or other immunosuppressant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RAD001 (Everolimus)
RAD001 (Everolimus)10 mg by mouth daily without interruption
|
10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001.
Time Frame: Two cycles of treatment with RAD001 (~6 weeks)
|
Two cycles of treatment with RAD001 (~6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: From entry in trial to up to 60 months
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From entry in trial to up to 60 months
|
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Progression-free Survival
Time Frame: From entry into trial to up to 60 months
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From entry into trial to up to 60 months
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|
Objective Response Rate
Time Frame: From beginning of treatment up to 60 months
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Number of patients for which response to treatment was observed / total number of patients.
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From beginning of treatment up to 60 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ahmad Tarhini, MD, PhD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
September 6, 2006
First Submitted That Met QC Criteria
September 6, 2006
First Posted (Estimate)
September 8, 2006
Study Record Updates
Last Update Posted (Actual)
October 19, 2017
Last Update Submitted That Met QC Criteria
September 18, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Everolimus
Other Study ID Numbers
- 06-049
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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