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Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00374140
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : February 27, 2014
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Ahmad Tarhini, University of Pittsburgh

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: RAD001 (everolimus) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer
Study Start Date : October 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Everolimus

Arms and Interventions
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Arm Intervention/treatment
Experimental: RAD001 (Everolimus)
RAD001 (Everolimus)10 mg by mouth daily without interruption
 Drug: RAD001 (everolimus)
10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
Other Name: Certican®


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From entry in trial to up to 60 months ]
  2. Progression-free Survival [ Time Frame: From entry into trial to up to 60 months ]
  3. Objective Response Rate [ Time Frame: From beginning of treatment up to 60 months ]
    Number of patients for which response to treatment was observed / total number of patients.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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).
  3. 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.
  4. ECOG performance status 0-2.
  5. 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.
  6. No progressive brain metastases. Brain metastases should have been previously treated with surgery and/or radiation.
  7. 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.
  8. No other coexisting medical condition that would preclude full compliance with the study.

  9. 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).
  10. Age >/= 18 years and capacity to give informed consent.
  11. 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.
  12. All patients must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

  1. Prior treatment with any investigational agent within the preceding 4 weeks.
  2. 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).
  3. A known history of HIV seropositivity.
  4. 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).
  5. Patients with an active, bleeding diathesis or on anticoagulation (except low dose warfarin).
  6. 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.
  7. 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.
  8. Patients should not be on chronic systemic glucocorticoids or other immunosuppressant.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374140


Locations
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Sponsors and Collaborators
Ahmad Tarhini
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Ahmad Tarhini, MD, PhD University of Pittsburgh
More Information
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Responsible Party: Ahmad Tarhini, Study Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00374140    
Other Study ID Numbers: 06-049
First Posted: September 8, 2006    Key Record Dates
Results First Posted: February 27, 2014
Last Update Posted: October 19, 2017
Last Verified: September 2017
Keywords provided by Ahmad Tarhini, University of Pittsburgh:
small cell
lung
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs