Dose Escalation Study of RAD001 in Combination w/Chemotherapy & Radiation in Patients With NSCLC

NCT01063478 | Terminated Phase 1 DMC

• 1 other identifier: 09-384-B
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand the effects (good and/or bad) of the addition of RAD001 to standard radiation and chemotherapy (cisplatin and pemetrexed) for patients with non-small cell lung cancer.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell; Lung Cancer; Unresectable advanced NSCLC

Outcome Measures

Primary Outcomes (1)

• To evaluate the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of RAD001 when administered in combination with chemotherapy and radiation.

  9/2011

Secondary Outcomes (1)

• To evaluate the preliminary clinical benefit rate after administration of RAD001 in combination with chemotherapy and radiation.

  3/2012

Study Arms (1)

RAD001, Chemotherapy, Radiation

EXPERIMENTAL

RAD001 + Chemotherapy and Radiation

Drug: RAD001 (in addition to standard radiation and chemotherapy)

Interventions

RAD001 (in addition to standard radiation and chemotherapy) DRUG

Standard radiation and chemotherapy (cisplatin and pemetrexed) + RAD001

Also known as: RAD001 (Everolimus)

RAD001, Chemotherapy, Radiation

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed NSCLC of any type
• Disease stage. Patients with unresectable stage II, stage III, and Mx are eligible. This includes patients who are being considered as surgical candidates after induction chemoradiation. Patients with Mx or M1 disease whose life-span and prognosis are felt to be dominated by the locoregional disease in the chest and are candidates for chemoradiotherapy are also eligible.
• Patients with pleural effusion that is transudative, cytologically negative and non- bloody are eligible if the radiation oncologist feels that the tumor can be encompassed within a reasonable field of radiotherapy.
• If a pleural effusion is of such a small size that a thoracentesis is not possible, then the patient is eligible
• Patients with malignant pleural or pericardial effusions are not eligible
• Patients will be eligible with or without measurable or evaluable disease. Patients with both measurable and evaluable disease will be evaluated for criteria for measurable disease
• Measurable disease is defined according to RECIST criteria
• Evaluable disease is defined as lesions apparent on CT which do not fit criteria for measurability.
• Ill defined masses associated with post obstructive changes
• Mediastinal or hilar adenopathy measurable in only one dimension
• Age ≥ 18 years
• ECOG performance status ≤ 2
• Life expectancy \> 6 months
• Adequate lung function as defined by an 02 saturation that is ≥ 90% on room air
• Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hb \>9 g/dL Adequate liver function as shown by: serum bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases), INR and PTT ≤1.5. (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for \>2 weeks at time of randomization.)

You may not qualify if:

• Patients who have received prior radiation or chemotherapy for the current diagnosis of NSCLC (patients who received surgery only for a prior NSCLC are eligible if the current diagnosis is felt to represent a new primary, and the PFT's would allow for concurrent chemoradiation)
• Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
• Prior treatment with any investigational drug within the preceding 4 weeks
• Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
• Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
• Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or breast DCIS, who may be included if the diagnosis was within 3 years.
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
• unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug
• serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
• symptomatic congestive heart failure of New York heart Association Class III or IV
• uncontrolled diabetes as defined by fasting serum glucose \>1.5 x ULN
• active (acute or chronic) or uncontrolled severe infections
• liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
• 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)

Sponsors & Collaborators

• University of Chicago: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Everolimus; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Therapeutics

Study Officials

• Everett E Vokes, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 5, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

US (1)