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Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01794845
Recruitment Status : Terminated (Early termination due to lack of efficacy (overall response))
First Posted : February 20, 2013
Results First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Information provided by (Responsible Party):
Matthew Abramowitz, University of Miami

Brief Summary:
Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma Head and Neck Cancer Recurrent Disease Drug: Erbitux Drug: Taxotere Radiation: Low Dose Fractionated Radiation Therapy Phase 2

Detailed Description:

The investigator's approach is based on the following reasons:

  • Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest.
  • LDFRT will render enhanced bax activation mediated mode of cell death.
  • Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death.
  • The toxicity profile is expected to be minimal.

Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
Actual Study Start Date : June 3, 2013
Actual Primary Completion Date : June 7, 2016
Actual Study Completion Date : June 7, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Erbitux, Taxotere, LD Fractionated RT
Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)
Drug: Erbitux
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
Other Name: Cetuximab

Drug: Taxotere
Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
Other Name: Docetaxel

Radiation: Low Dose Fractionated Radiation Therapy
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Other Name: LDFRT

Primary Outcome Measures :
  1. Overall Response Rate (ORR) of Participants [ Time Frame: Up to 6 months from End of Treatment, about 9 months ]
    ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.

Secondary Outcome Measures :
  1. Number of Study Participants Experiencing Treatment-Related Toxicity [ Time Frame: Up to 6 years ]

    Assess the safety profile (acute and late toxicities) of the proposed treatment. Number of study participants experiencing treatment-related acute and late toxicity:

    • Acute toxicity is defined as toxicity occurring within 90 days of start of therapy.
    • Late/Long-term toxicity defined as toxicity occurring more than 90 days after start of therapy.

  2. Estimated Progression-Free Survival (PFS) [ Time Frame: Up to 6 years ]
    Progression-free survival (PFS) is defined of the length of time from the start date of treatment to the earliest documented occurrence of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria. In the absence of an event constituting failure, follow up time will be censored at the date of last disease assessment.

  3. Estimated Overall Survival (OS) [ Time Frame: Up to 6 years ]
    Overall survival (OS) is defined as the length of time from the start of treatment that study participants diagnosed with the disease are still alive. OS will be measured from the start date of treatment to the date of death or last contact (censored observations).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract .Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥ 6 months following the end of the prior RT.
  2. The recurrence must have defined bi- or uni-dimensional measurements.
  3. Recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence).
  4. The patient must not be a candidate for surgical resection.
  5. Patients must be at least 6 months from completion of prior chemotherapy and radiation therapy.
  6. Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
  7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  8. Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum bilirubin ≤ 1.5 mg/dl, creatinine < 1.5 mg/dl within 3 weeks prior to registration.
  9. Liver Function Tests (LFTs) ≤ 2 x normal (serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic-pyruvic transaminase (SGPT)/Alkaline Phosphatase). If > 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
  10. Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

  1. Distant metastases outside of the head and neck.
  2. Primary disease in the nasopharynx or the salivary gland.
  3. Other concurrent invasive malignancies.
  4. Prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are permissible).
  5. Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
  6. Pre-existing grade ≥ 2 peripheral sensory neuropathy
  7. Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
  8. Prior history of sever hypersensitivity reaction to Docetaxol, Cetuximab or a drug with formulated with Polysorbate 80.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01794845

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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Principal Investigator: Matthew C Abramowitz, MD University of Miami
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Responsible Party: Matthew Abramowitz, Assistant Professor of Clinical, University of Miami Identifier: NCT01794845    
Other Study ID Numbers: 20090467
First Posted: February 20, 2013    Key Record Dates
Results First Posted: May 11, 2017
Last Update Posted: May 11, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Matthew Abramowitz, University of Miami:
Head and Neck Cancer
Squamous Cell Carcinoma
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Neoplasms, Squamous Cell
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological