Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Small-Cell Lung Cancer	Drug: Everolimus	Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Sirolimus Etoposide phosphate Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1 [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen [ Time Frame: within 6 cycles (Day 126) ] [ Designated as safety issue: No ]
PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles [ Time Frame: During the first 6 cycles ] [ Designated as safety issue: Yes ]
Overall tumor response [ Time Frame: Every 6-8 weeks ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	April 2007
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Daily dosing RAD001	Drug: Everolimus RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language. Other Name: RAD001
Experimental: Weekly dosing RAD001	Drug: Everolimus RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language. Other Name: RAD001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466466

Locations

United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Massachusetts
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
France
Novartis Investigative Site
Paris, France

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00466466 History of Changes
Other Study ID Numbers:	CRAD001C2116
Study First Received:	April 26, 2007
Last Updated:	November 21, 2011
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency France: Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS)

Keywords provided by Novartis:

Small-Cell Lung Cancer
SCLC
Advanced Lung Cancer
RAD

RAD001
Chemotherapy
Cisplatin
Etoposide

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
Etoposide phosphate
Cisplatin
Etoposide
Sirolimus

Everolimus
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Immunosuppressive Agents
Immunologic Factors
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013