Clinical trial NCT00466466: Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients
Official title: A Phase Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Small-Cell Lung Cancer
Keywords: Small-Cell Lung Cancer
SCLC
Advanced Lung Cancer
RAD
RAD001
Chemotherapy
Cisplatin
Etoposide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.


Eligibility criteria: Inclusion criteria:

* Patients with histologically or cytologically confirmed diagnosis of extensive disease small-cell lung cancer (ED SCLC)
* Age ≥ 18 years
* WHO Performance Status Grade ≤ 1 (ie. ability to perform normal daily functions)
* Adequate bone marrow, liver and renal function

Exclusion criteria:

* Chronic steroid treatment
* Prior treatment with chemotherapy for advanced lung cancer
* Prior treatment with mTOR inhibitors
* Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions
* Symptomatic or uncontrolled brain metastases
* Other cancers within the past 5 years
* Pregnant or breastfeeding women

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1
timeFrame: Day 21
Secondary outcomes:
measure: Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen
timeFrame: within 6 cycles (Day 126)
measure: PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles
timeFrame: During the first 6 cycles
measure: Overall tumor response
timeFrame: Every 6-8 weeks
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Boston
country: United States
facility: Dana Faber Cancer Institute
state: Massachusetts
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center at UTHSCSA
state: Texas
city: Paris
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: