Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma

This study has been terminated.
(PI left institution.)
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01009203
First received: November 5, 2009
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

The primary hypothesis of this study is that the addition of mammalian target of rapamycin (mTOR) blockade to conventional epidermal growth factor receptor (EGFR) blockade will result in synergistic clinical activity in Squamous Cell Carcinoma of the Head and Neck (SCCHN), consistent with the preclinical xenograft data. The primary signal of efficacy will be progression free survival (PFS), anticipating that PFS will be prolonged compared to historical PFS in SCCHN patients treated with Tarceva or cetuximab monotherapy.


Condition Intervention Phase
Squamous Cell Carcinoma
Drug: Tarceva, Torisel
Drug: 28-day cycles of Tarceva 150 mg by mouth daily and Torisel 15 mg IV weekly
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory or -Ineligible, Advanced, Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the toxicities of the combination of Torisel and Tarceva in patients with advanced, platinum-refractory or -ineligible SCCHN. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: December 2009
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
28-day cycles of Tarceva 150 mg by mouth daily and Torisel 15 mg IV weekly
Drug: Tarceva, Torisel
Torisel 15 mg IV weekly and Tarceva 150 mg po daily. In the absence of Grade 3 or higher toxicity, a single, intra-patient dose increase of Torisel to 20 mg IV weekly is permitted after the first 28 day cycle.
Other Names:
  • erlotinib
  • OSI-774
  • temsirolimus
  • CCI-779
Drug: 28-day cycles of Tarceva 150 mg by mouth daily and Torisel 15 mg IV weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009203

Locations
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Genentech
Investigators
Principal Investigator: Homan Fekrazad, MD University of New Mexico Cancer Center
  More Information

Publications:
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01009203     History of Changes
Other Study ID Numbers: INST OSI4641s, OSI4641s, NCI-2011-02948
Study First Received: November 5, 2009
Last Updated: July 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
squamous cell carcinoma
head
neck
aerodigestive

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Sirolimus
Everolimus
Erlotinib
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014