Combination of Cisplatin, Cetuximab and Temsirolimus in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT01015664 | Terminated Phase 1 DMC

• 1 other identifier: HN0209
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study will accrue in two "phases". During the first "phase" of the study, the optimal dose of temsirolimus in combination with cisplatin and cetuximab will be determined. It is expected that between 9-12 patients will be needed for this dose finding phase. Once the optimal dose has been determined, an additional 41 patients will be enrolled in the second "phase" of the study. The primary purpose of second phase of the study is to learn what effects, good and/or bad, temsirolimus in combination with cisplatin and cetuximab has on recurrent or metastatic head and neck cancer. Collection of additional blood and tissue specimens will make it possible to do special tests, which will provide us information about how tumors respond to the chemotherapy, how your body breaks down and processes the drug, how differences in the genetic makeup of each person affects how the drug may work and is processed in the body, and how the drug affects proteins and cells in the body. We hope to determine if results of the specialized tests done on blood will help to predict which patients are more likely to benefit from the use of the drugs used in this study.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (2)

• Phase one - the outcome measure for determining the optimal dose will be determined by whether the subjects experience a dose limiting toxicity (DLT)

• Phase 2 - the outcome measure of Progression-Free Survival is defined as the time from first treatment to the documented progression of disease or death, whichever comes first.

Secondary Outcomes (3)

• Overall response rate is defined as the proportion of patients achieving any response (CR + PR) compared to the total patient population.

• Disease control rate is defined as the proportion of patients who achieve a CR, PR, or SD (for ≥ 12 weeks) during study treatment compared to the total patient population.

• Overall survival is defined as the time from first treatment to the time of death, regardless of cause.

Interventions

temsirolimus DRUG

10, 15, or 25 mg IV over 30 minutes on Days 1, 8, 15 and 22

Also known as: Torisel

cisplatin DRUG

75 mg/m2 IV over 60 minutes on day 1

Also known as: Platinol

cetuximab DRUG

400 mg m2 on Day 1 of Cycle 1, then 250 mg/m2 IV over 60 minutes on Days 1, 8, 15, and 22

Also known as: Erbitux

Eligibility Criteria

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

You may qualify if:

• Patients must be ≥ 18 years of age and have a histologically confirmed diagnosis of R/M SCCHN which is no longer amenable to curative surgical or radiation therapy.
• Patients must sign a written informed consent form and HIPAA statement.
• Patients must undergo biopsy for confirmation of R/M disease within 6 weeks (42 days) of study entry and be willing and able to comply with peripheral blood collections for the purpose of correlative studies. Biopsy of primary or metastatic site(s) is allowed, provided the site has not been previously irradiated.
• Patients must have measurable disease as defined by RECIST.
• Patients must have ECOG PS 0 or 1.
• Patients must have adequate hematologic function as defined by an ANC ≥ 1,500, hemoglobin ≥ 10 g/dL, and a platelet count ≥ 75,000 obtained within 14 days prior to treatment.
• Patients must have adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL and AST (SGOT) and ALT (SGPT) ≤ 2 times the ULN obtained within 14 days prior to treatment.
• Patients must have adequate renal function defined as a serum creatinine ≤ 1.5 mg/dL or calculated CrCl ≥ 55 mL/minute (calculations should be conducted using the Cockroft-Gault equation).
• Patients must have adequate lipid control defined as a serum cholesterol ≤ 350 mg/dL and serum triglycerides ≤ 300 mg/dL obtained within 14 days prior to treatment.
• Patients must not have received previous chemotherapy for the treatment of R/M SCCHN. Previous curative-intent treatment with chemotherapy, radiation therapy, chemoradiotherapy, or surgery for locoregional disease is allowed provided at least 3 months have elapsed since the completion of previous therapies and the patient has recovered from all treatment related toxicities.
• Patients may have received prior radiation therapy for symptomatic sites of disease progression provided that ≥ 21 days have elapsed since treatment and the patient has recovered from any treatment related toxicities.
• Males and females of reproductive potential must agree to use effective contraception for the duration of study participation.

You may not qualify if:

• Patients with active or prior CNS metastases.
• Patients with a history of previous hypersensitivity reaction to study drugs.
• Patients with other active malignancies are excluded. Patients with a history of non-melanoma skin cancers, in-situ cervical cancer, definitively treated stage I or II cancers from which the patient is in remission, or a history of other malignancies from which the patient has been disease free for ≥ 5 years are permitted.
• Concurrent therapy with any other anti-cancer treatments.
• Ongoing or active clinically serious infection requiring IV antibiotics or active HIV infection.
• Patients with a history of symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any medical condition that could compromise the safety of the patient.
• Patients with, in the best judgment of the investigator, psychosocial, family, sociological, or geographical limitations which could impact the patient's ability to comply with study procedures.
• Pregnant or lactating females.
• Employees of the investigator or study center with direct involvement in this or other studies under the direction of the investigative team.
• Patients currently taking any of the following medications are ineligible: phenytoin, carbamazepine, phenobarbitor, and/or rifampin as these are all strong Cyp3A4/5 inducers.

Sponsors & Collaborators

• University of Tennessee Cancer Institute: lead
• National Comprehensive Cancer Network: collaborator

Study Sites (1)

Boston Baskin Caner Foundation

Memphis, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

temsirolimus; Cisplatin; Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

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

Study Officials

• Furhan Yunus, MD

  University of Tennessee Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

US (1)