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A Phase II Study of Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory or -Ineligible, Advanced, Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Squamous Cell Carcinoma

Thank you

Trial Information

A Phase II Study of Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory or -Ineligible, Advanced, Squamous Cell Carcinoma of the Head and Neck


Inclusion Criteria:



1. Histologically or cytologically confirmed squamous cell carcinoma of the head and
neck, from any primary site. Nasopharyngeal carcinoma, 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 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. 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, AST and 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 Torisel or Tarceva

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the clinical efficacy of the combination of Torisel and Tarceva in patients with advanced, platinum-refractory or -ineligible, squamous cell carcinoma of the head and neck.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Homan Fekrazad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

INST OSI4641s

NCT ID:

NCT01009203

Start Date:

December 2009

Completion Date:

December 2012

Related Keywords:

  • Squamous Cell Carcinoma
  • squamous cell carcinoma
  • head
  • neck
  • aerodigestive
  • Carcinoma
  • Carcinoma, Squamous Cell

Name

Location

University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
University of New Mexico Cancer Center @ Lovelace Medical CenterAlbuquerque, New Mexico  87102