Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00457119
First received: April 4, 2007
Last updated: February 9, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: RAD001
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate [ Time Frame: Ever 3 months or once a critical DLT occurs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1) [ Time Frame: End of step 1 ] [ Designated as safety issue: Yes ]
  • Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2) [ Time Frame: End of Step 2 ] [ Designated as safety issue: Yes ]
  • PK parameters derived from PK profiles of treatment drugs alone and in combination [ Time Frame: End of Step 1 and Step 2 ] [ Designated as safety issue: No ]
  • Best overall response - measured by CT/MRI scan every 6-8 week [ Time Frame: Every 6-8 week ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: February 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Step 1 Arm 1
5mg/day RAD001 + Carboplatin + Paclitaxel
Drug: RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Other Name: Everolimus
Experimental: Step 1, Arm 2
30mg/week RAD001 + Carboplatin + Paclitaxel
Drug: RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Other Name: Everolimus
Experimental: Step 2, Arm 1
5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab
Drug: RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Other Name: Everolimus
Experimental: Step 2, Arm 2
30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab
Drug: RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Other Name: Everolimus

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

Ages Eligible for Study:   23 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00457119

Locations
United States, District of Columbia
Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114
Washington, District of Columbia, United States, 20007-2197
United States, Louisiana
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
New Orleans, Louisiana, United States, 70115
United States, Texas
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
Dallas, Texas, United States, 75390-9151
MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc.
Houston, Texas, United States, 77030-4009
Australia, South Australia
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Novartis Investigative Site
Heidelberg, Victoria, Australia, 3084
Germany
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Heidelberg, Germany, 69126
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00457119     History of Changes
Other Study ID Numbers: CRAD001C2114, 2006-002760-26
Study First Received: April 4, 2007
Last Updated: February 9, 2013
Health Authority: United States: Food and Drug Administration
Australia: National Health and Medical Research Council
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Non Small Cell Lung Cancer
NSCLC
Advanced Lung Cancer
RAD
RAD001
chemotherapy
carboplatin
paclitaxel
bevacizumab

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Carboplatin
Everolimus
Paclitaxel
Sirolimus
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 20, 2014