Clinical trial NCT00406276 (phase 1/phase 2, status: terminated)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: rad001, docetaxel
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](O)[C@@H](C1)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    data analysis showed insufficient drug efficacy
  
Eligibility criteria:

        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
             protocol.

          -  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 treatment.

          -  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
             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.

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

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