Clinical trial NCT01009203 (phase 2, status: terminated)
Conditions: squamous cell carcinoma
ICD codes: C44.520, C44.92, C44.02, C44.321, C44.521, C44.82, C44.42
Drugs: erlotinib, temsirolimus
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, CN1N=NC2=C(N=CN2C1=O)C(N)=O
Reason stopped: 
    high patient withdrawal rate
  
Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed squamous cell carcinoma of the head and
             neck, from any primary site. Nasopharyngeal carcinoma, World Health Organization (WHO)
             Grade I, will be included.

          2. Advanced disease, fulfilling one of the criteria defined below:

               -  Incurable disease as assessed by surgical or radiation oncology

               -  Metastatic (M1) disease

               -  Persistent or progressive disease following curative-intent radiation, and not a
                  candidate for surgical salvage due to incurability or morbidity

          3. Platinum-refractory or platinum-ineligible, fulfilling one of the criteria defined
             below:

               -  disease progression during or after 4-6 cycles of platinum-containing therapy in
                  the advanced setting

               -  disease progression within 6 months of curative-intent treatment, which included
                  platinum-based chemotherapy

               -  ineligible for platinum-containing therapy, in the opinion of the medical
                  oncologist, due to medical comorbidities or unacceptable risk for toxicity

               -  patient refuses platinum-containing therapy

          4. Measurable disease based on response evaluation criteria in solid tumors (RECIST)

             - disease in previously irradiated sites is considered measurable if there has been
             unequivocal progression of the lesion after radiotherapy, or the lesion contains
             residual carcinoma by biopsy more than 6 weeks after completion of radiotherapy

          5. Easter Cooperative Oncology Group (ECOG) performance status 0-2 at time of informed
             consent

          6. Adequate hematologic reserve and organ function

               -  Absolute neutrophil count > 1200/µl

               -  Platelet count > 100,000/µl

               -  Renal function: Serum Creatinine ≤ 1.5x upper limit of normal (ULN)

               -  Liver function: Total bilirubin ≤ 1.5x ULN, Aspartate aminotransferase (AST) and
                  alanine aminotransferase (ALT) ≤ 2.5x ULN

          7. Able to provide written, voluntary consent

          8. Patients with reproductive potential must use an effective contraceptive method.

          9. Male or female, age ≥ 18 years

         10. Life expectancy ≥ 12 weeks

        Exclusion Criteria:

          1. Nasopharyngeal primary site, if WHO grade II or III

          2. Prior treatment blocking the epidermal growth factor receptor (EGFR), in the advanced
             disease setting

          3. Prior treatment blocking EGFR in the curative-intent setting, if delivered in the
             previous 6 months

          4. Prior treatment with a drug blocking the mammalian target of rapamycin (mTOR)

          5. Sensitivity to temsirolimus or erlotinib

          6. Uncontrolled metastatic disease of the central nervous system

          7. Radiotherapy within the 2 weeks before Cycle 1' Day 1

          8. Surgery within the 2 weeks before Cycle 1' Day 1

          9. Pregnant or lactating females

         10. Myocardial infarction or ischemia within the 6 months preceding study treatment

         11. Any co morbid condition that' in the view of the attending physician' renders the
             patient at high risk from treatment complications

         12. No other concurrent, investigational anti-neoplastic agent will be permitted

         13. History of prior malignancy within the prior five years, with the exception of
             non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix