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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Ahmad Tarhini, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00374140
First received: September 6, 2006
Last updated: January 8, 2014
Last verified: December 2013
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Drug: RAD001 (everolimus)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To Determine Overall Survival, Progression-free Survival, Objective Response Rate, and Toxicities. [ Time Frame: Followed until progression and death ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: October 2006
Study Completion Date: July 2012
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374140

Locations
United States, Ohio
UPMC Cancer Center - Teramana Cancer Center - Steubenville
Steubenville, Ohio, United States, 43952
United States, Pennsylvania
UPMC Cancer Center - Beaver
Beaver, Pennsylvania, United States, 15009
UPMC Cancer Center - Clairton
Clairton, Pennsylvania, United States, 15025
UPMC Cancer Center - Oakbrook Commons - Greensburg
Greensburg, Pennsylvania, United States, 15601
UPMC Cancer Center - Arnold Palmer Pavilion - Greensburg
Greensburg, Pennsylvania, United States, 15601
UPMC Cancer Center - Indiana
Indiana, Pennsylvania, United States, 15701
UPMC Cancer Center - John P. Murtha Pavilion - Johnstown
Johnstown, Pennsylvania, United States, 15901
UPMC Cancer Center - McKeesport
McKeesport, Pennsylvania, United States, 15132
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, United States, 15146
UPMC Cancer Center - Sewickley Medical Oncology/Hematology Group
Moon Township, Pennsylvania, United States, 15108
UPMC Cancer Center - New Castle
New Castle, Pennsylvania, United States, 16105
UPMC Cancer Center - Passavant
Pittsburgh, Pennsylvania, United States, 15237
UPMC Cancer Center - St. Margaret's
Pittsburgh, Pennsylvania, United States, 15215
UPMC Cancer Center - Mercy
Pittsburgh, Pennsylvania, United States, 15219
UPMC Cancer Center - Upper St. Clair
Pittsburgh, Pennsylvania, United States, 15241
University of Pittsburgh Cancer Institute - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
UPMC Cancer Center - Uniontown
Uniontown, Pennsylvania, United States, 15401
UPMC Cancer Center - Washington
Washington, Pennsylvania, United States, 15301
UPMC Cancer Center - North Hills
Wexford, Pennsylvania, United States, 15090
Sponsors and Collaborators
Ahmad Tarhini
Novartis Pharmaceuticals
Investigators
Principal Investigator: Ahmad Tarhini, MD, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Ahmad Tarhini, Study Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00374140     History of Changes
Other Study ID Numbers: 06-049
Study First Received: September 6, 2006
Results First Received: January 8, 2014
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
small cell
lung

Additional relevant MeSH terms:
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
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 18, 2014