Trial of RAD001 in Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00401778

Last Updated: 2016-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2013-12-31

Brief Summary

This is a Phase 1b pre-operative lung cancer trial wherein patients with operable lung cancer will be treated with RAD001 to evaluate the target effects of this compounds on relevant molecular pathways and on the 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) uptake of the tumor by a positron emission tomography (PET) scan at baseline and immediately prior to surgery. The safety profile of RAD001 will also be evaluated.

Detailed Description

This is a Phase 1b pre-operative lung cancer trial wherein patients with operable lung cancer will be treated with RAD001 for 3-4 weeks to study the effects of the novel agent in relevant molecular pathways. The study will also assess the FDG uptake of the tumor at baseline and upon completion of therapy (before surgery) with a PET scan. The safety profile of RAD001 will also be evaluated.

New agents and regimens are urgently needed for lung cancer treatment. With the development of novel agents and small molecules designed to curtail the aggressive aspects of this disease, some progress has been realized. However, much more effort and insight will be required for further real gains to be made. We propose that studying the mammalian target of rapamycin (mTOR) axis, known to be abnormal in non-small cell lung cancer (NSCLC), and translating that knowledge into therapeutic adjustments can lead to meaningful advances in lung cancer treatment.

Approximately 35 patients will participate at Winship Cancer Institute of Emory University in Atlanta, Georgia.

Conditions

Lung Cancer

Keywords

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

RAD001 5 mg/day for 21 days sequentially.

Group Type: ACTIVE_COMPARATOR

RAD001

Intervention Type: DRUG

Patients will be assigned to one of three treatment arms with RAD001 doses of 5, and 10 mg/day for 21-28 days sequentially taken orally in tablet form.

3

RAD001 10 mg/day for 21 days sequentially.

Group Type: ACTIVE_COMPARATOR

RAD001

Intervention Type: DRUG

Patients will be assigned to one of three treatment arms with RAD001 doses of 5, and 10 mg/day for 21-28 days sequentially taken orally in tablet form.

Control

Patients who are eligible for the study but choose not to receive RAD001 treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RAD001

Patients will be assigned to one of three treatment arms with RAD001 doses of 5, and 10 mg/day for 21-28 days sequentially taken orally in tablet form.

Intervention Type: DRUG

Other Intervention Names

Everolimus

Eligibility Criteria

Inclusion Criteria

• Patient must have histologically confirmed Stage I-IIIA non-small cell lung cancer (NSCLC) which is accessible to biopsy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
• Life-expectancy greater than 6 months.
• Adequate bone marrow, renal, hepatic, pulmonary and cardiac function as defined in the protocol.
• Patient must be at least 18 years of age.
• Must meet pre-entry requirements for timing of study parameters as specified in section 7.0.
• Female patients of child-bearing potential must have a negative serum pregnancy test within 48 hours of study initiation and be non-lactating.
• Patients of child-bearing potential must agree to use an effective form of contraception while on study and for 3 months following completion of study treatment.
• The use of granulocyte-colony stimulating factor (G-CSF) will be permitted in study participants.
• Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria

• Patient has received previous treatment for NSCLC.
• Known hypersensitivity to everolimus, sirolimus, or any of its excipients.
• Patient is pregnant or breast-feeding.
• Patient has incurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patient is unable to swallow RAD001 tablet.
• History of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of the malignancy being present within the past five years.
• History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. Symptoms may include any reaction such as bronchospasm, generalized urticaria, systolic BP ≤ 80mm Hg, and angioedema.
• Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Suresh S. Ramalingam

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suresh Ramalingam, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Winship Cancer Institute

Locations

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00024810

Identifier Type: -

Identifier Source: org_study_id