Torisel in Addition to Standard Chemotherapy With Radiation for Advanced Head and Neck Cancer

NCT01326468 | Withdrawn DMC

• 3 other identifiers: 10D.1332009-44JT 1537
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with advanced head and neck cancer is at high risk of recurrence at the primary site or in the neck. Part of normal treatment is to treat such patients with chemotherapy and radiation. The chemotherapy can include Erbitux. The purpose of this study is to treat such patients with an additional agent, Torisel. This study tests the doses of Torisel that can be safely administered together with radiation and chemotherapy.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; temsirolimus; cetuximab; cisplatin; radiation therapy

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Torisel

  To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Torisel (Torisel) when given with chemoradiotherapy (radiosensitized radiotherapy with cetuximab, cisplatin or both).

  7 weeks

Secondary Outcomes (1)

• Progression-Free Survival

  12 months

Study Arms (2)

Cohort A - Temsirolimus with Cisplatin

EXPERIMENTAL

Temsirolimus with cisplatin, Erbitux and radiation therapy

Drug: Temsirolimus; Drug: Cetuximab; Drug: Cisplatin; Device: Radiation Therapy

Cohort B - Temsirolimus

EXPERIMENTAL

Temsirolimus with Erbitux and radiation therapy

Drug: Temsirolimus; Drug: Cetuximab; Device: Radiation Therapy

Interventions

Temsirolimus DRUG

All patients will receive temsirolimus. The dose of temsirolimus in this study will range from 15-25 mg depending on the dose level. Temsirolimus will be infused over a 30-60 minute period once a week for the duration of radiation therapy.

Also known as: Torisel, CCI-779

Cohort A - Temsirolimus with Cisplatin; Cohort B - Temsirolimus

Cetuximab DRUG

All patients will receive cetuximab. An initial loading dose of cetuximab 400 mg/m2, intravenously over 120 minutes at least 4 days before radiation therapy but no more than 7 days before the start of radiation therapy. Thereafter, cetuximab will be infused at 250 mg/m2 dose over 60 minutes weekly for the duration of radiation therapy.

Also known as: IMC-C225, Erbitux

Cohort A - Temsirolimus with Cisplatin; Cohort B - Temsirolimus

Cisplatin DRUG

All patients in Cohort A will receive cisplatin. The dose will be 20 mg/m2 or 30 mg/m2 depending upon the dose level.

Also known as: cisplatinum, cis-diamminedichloroplatinum(II), CDDP, Platinol, Platinol-AQ

Cohort A - Temsirolimus with Cisplatin

Radiation Therapy DEVICE

Patients will be treated on a linear accelerator fitted with multi-leaf collimators with 1.6-2.3 Gy fractions delivered daily 5 days per week over 4-7 weeks to a cumulative dose of 66 Gy. A variance of +/- 10% in this nominal prescription dose is allowable and will depend on the extent of residual disease, at the discretion of the attending radiation oncologist.

Also known as: IMRT, RT, radiation oncology, radiotherapy, XRT

Cohort A - Temsirolimus with Cisplatin; Cohort B - Temsirolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort A:
• Stage III or IVA-B HNC without prior RT except non-sm0kers with human papillomavirus (HPV) + nasopharynx and oropharynx. HPV+ oropharynx patients who have smoked regularly in the past 5 years are eligible.
• Patients with local or regional recurrence after surgery alone are eligible, as long as the recurrent stage is III or IVA-B
• Age \> or = 18
• Karnofsky performance status \> 70
• No severe active infection requiring intravenous antibiotics (oral antibiotics are allowable).
• Adequate renal function (creatinine \< 1.5 mg/dl), based upon blood work performed within 1 month prior to registration.
• Adequate hepatic function (alkaline phosphatase and AST/ALT \< 2 x ULN) based upon bloodwork performed within 1 month prior to registration.
• Adequate bone marrow function (ANC \> 1.5; platelets \> 100K) based upon blood work performed within one month prior to registration.
• Adequate cardiopulmonary function (no signs of acute coronary event and/or active CHF).
• No plans for other concurrent radiation therapy, chemotherapy or biologic anti-cancer therapy.
• Cohort B:
• Platinum ineligible patients as defined by the multidisciplinary team.
• Stage III or IVA-B HNC without prior RT except nonsmokers with HPV + nasopharynx and oropharynx. HPV+ oropharynx patients who have smoked regularly in the past 5 years are eligible.
• Patients with local or regional recurrence after surgery alone are eligible, as long as the recurrent stage is III or IVA-B

You may not qualify if:

• Current, recent (within 4 weeks of enrollment in this study) or planned participation in an experimental drug study other than this one.
• KPS \< 70%
• Expected survival \< 6 months
• Early stage head and neck cancer as defined as T1N0 or T2N0 by AJCC 7th edition
• Poorly controlled blood pressure, defined as systolic bp \> 150 and/or diastolic bp \> 100 despite medication.
• Unstable angina.
• NY Heart Association (NYHA) Grade II or greater congestive heart failure.
• History of myocardial infarction or stroke within 6 months.
• Clinically significant peripheral vascular disease.
• Evidence of bleeding diathesis or coagulopathy.
• Presence of brain or spinal cord metastases.
• Major surgical procedure(s), open biopsy or significant traumatic injury within 14 days prior to initiation of radiation therapy and/or anticipation of need for major surgical procedure during the course of the study.
• Minor surgical procedures such as needle/core biopsies, dental work, PEG placement, tracheostomy within 10 days prior to initiation of radiation therapy.
• Carotid artery exposure or other signs of impending carotid artery hemorrhage.
• History of abdominal fistula and/or gastrointestinal abdominal abscess within 6 months prior to enrollment.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Pfizer: collaborator

Related Links

• Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Thomas Jefferson University Hospitals

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

temsirolimus; Cetuximab; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• Voichita Bar-Ad, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 30, 2011
• Study Start: December 8, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 25, 2025

Record last verified: 2025-09