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

NCT00374140 | Completed Phase 2 Results DMC

• 1 other identifier: 06-049
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 19

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.

Conditions

Small Cell Lung Cancer

Keywords

small cell; lung

Outcome Measures

Primary Outcomes (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.

  Two cycles of treatment with RAD001 (~6 weeks)

Secondary Outcomes (3)

• Overall Survival

  From entry in trial to up to 60 months

• Progression-free Survival

  From entry into trial to up to 60 months

• Objective Response Rate

  From beginning of treatment up to 60 months

Study Arms (1)

RAD001 (Everolimus)

EXPERIMENTAL

RAD001 (Everolimus)10 mg by mouth daily without interruption

Drug: RAD001 (everolimus)

Interventions

RAD001 (everolimus) DRUG

10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities

Also known as: Certican®

RAD001 (Everolimus)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmad Tarhini: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (19)

UPMC Cancer Center - Teramana Cancer Center - Steubenville

Steubenville, Ohio, 43952, United States

Location

UPMC Cancer Center - Beaver

Beaver, Pennsylvania, 15009, United States

Location

UPMC Cancer Center - Clairton

Clairton, Pennsylvania, 15025, United States

Location

UPMC Cancer Center - Arnold Palmer Pavilion - Greensburg

Greensburg, Pennsylvania, 15601, United States

Location

UPMC Cancer Center - Oakbrook Commons - Greensburg

Greensburg, Pennsylvania, 15601, United States

Location

UPMC Cancer Center - Indiana

Indiana, Pennsylvania, 15701, United States

Location

UPMC Cancer Center - John P. Murtha Pavilion - Johnstown

Johnstown, Pennsylvania, 15901, United States

Location

UPMC Cancer Center - McKeesport

McKeesport, Pennsylvania, 15132, United States

Location

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

UPMC Cancer Center - Sewickley Medical Oncology/Hematology Group

Moon Township, Pennsylvania, 15108, United States

Location

UPMC Cancer Center - New Castle

New Castle, Pennsylvania, 16105, United States

Location

UPMC Cancer Center - St. Margaret's

Pittsburgh, Pennsylvania, 15215, United States

Location

UPMC Cancer Center - Mercy

Pittsburgh, Pennsylvania, 15219, United States

Location

University of Pittsburgh Cancer Institute - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Cancer Center - Passavant

Pittsburgh, Pennsylvania, 15237, United States

Location

UPMC Cancer Center - Upper St. Clair

Pittsburgh, Pennsylvania, 15241, United States

Location

UPMC Cancer Center - Uniontown

Uniontown, Pennsylvania, 15401, United States

Location

UPMC Cancer Center - Washington

Washington, Pennsylvania, 15301, United States

Location

UPMC Cancer Center - North Hills

Wexford, Pennsylvania, 15090, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Ahmad Tarhini, MD, PhD
• Organization: University of Pittsburgh

tarhiniaa@upmc.edu

(412) 648-6578

Study Officials

• Ahmad Tarhini, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: September 6, 2006
• First Posted: September 8, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2012
• Last Updated: October 19, 2017
• Results First Posted: February 27, 2014

Record last verified: 2017-09

Locations

US (19)