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Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer

This is an open-label, single-arm, Phase I/II trial to determine the safety of RAD001 in
combination with docetaxel and compare the efficacy of RAD001 plus docetaxel versus
published Phase II and III reports of docetaxel alone in patients with recurrent NSCLC.

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 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 58 patients will participate at Emory Winship Cancer Institute and Emory
Crawford W. Long Hospital in Atlanta, Georgia.

Inclusion Criteria:

- Patients must have histologically confirmed non-small cell lung cancer (NSCLC) which
is accessible to biopsy.

- Patient must have ECOG Performance Status of 0, 1, or 2.

- Life expectancy greater than 12 weeks.

- Patient must have adequate bone marrow, renal and hepatic function as defined in the

- Completed all prior therapy at least 3 weeks prior to registration and be adequately
recovered from that therapy.

- Must be at least 18 years of age.

- Meet pre-entry requirements as specified in Section 7.0.

- Female patients of child-bearing potential must have a negative serum pregnancy test
prior to study entry.

- 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

- Patient must not have more than one prior chemotherapy regimen.

- Final eligibility for a clinical trial is determined by the health professionals
conducting the trial.

Exclusion Criteria:

- Chronic treatment with systemic steroids or other immunosuppressive agents.

- Uncontrolled brain or leptomeningeal metastases, including patients who continue to
require glucocorticoids for brain or leptomeningeal metastases.

- 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).

- Patients with an active, bleeding diathesis or an oral anti-vitamin K medication
(except low dose coumadin).

- Known hypersensitivity to everolimus, sirolimus, or any of its excipients.

- Patient is pregnant or breast-feeding.

- Patient has intercurrent illness including, but not limited to: ongoing active or
severe infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, uncontrolled hypertension, myocardial infarction within 6 months,
uncontrolled diabetes mellitus, chronic liver or renal disease, active upper GI tract
ulceration or psychiatric illness/social situations that would limit compliance with
study requirements.

- Patient is unable to swallow RAD001.

- History of other invasive malignancies, with the exception of non-melanoma skin
cancer, if there is any evidence of the malignancy being present within the past 5

- 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.

- Patient has received treatment with an investigational agent within 4 weeks of

- Final eligibility for a clinical trial is determined by the health professionals
conducting the trial.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Subjects Showing Partial Response and Stable Disease With the Combination of RAD001 and Docetaxel.

Outcome Description:

Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as reference the smallest sum Longest diameter(LD) since treatment started.

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Suresh Ramalingam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

November 2006

Completion Date:

May 2013

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Emory University Winship Cancer Institute Atlanta, Georgia  30322