Clinical trial NCT00457119: Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients
Official title: A Two-step Phase 1 Study Investigating the Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients Not Treated Previously With Systemic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
NSCLC
Advanced Lung Cancer
RAD
RAD001
chemotherapy
carboplatin
paclitaxel
bevacizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-04-05
Enrollment: 69
Sex: ALL
Minimum age (years): 23
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD 001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab

Detailed description: This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001 is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced disease

Eligibility criteria: Inclusion criteria:

* Age over 18 years
* Advanced Non Small Cell Lung Cancer (Stage IIIB/IV)
* Ability to perform normal daily functions

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
* Known sensitivity to platinum compounds, taxanes or bevacizumab
* Other cancers within the past 5 years
* Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate
timeFrame: Ever 3 months or once a critical DLT occurs
Secondary outcomes:
measure: Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1)
timeFrame: End of step 1
measure: Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2)
timeFrame: End of Step 2
measure: PK parameters derived from PK profiles of treatment drugs alone and in combination
timeFrame: End of Step 1 and Step 2
measure: Best overall response - measured by CT/MRI scan every 6-8 week
timeFrame: Every 6-8 week
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114
state: District of Columbia
city: New Orleans
country: United States
facility: LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
state: Louisiana
city: Dallas
country: United States
facility: U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc.
state: Texas
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: