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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Matthew Abramowitz, University of Miami

Tracking Information
First Submitted Date  ICMJE February 14, 2013
First Posted Date  ICMJE February 20, 2013
Results First Submitted Date  ICMJE February 8, 2017
Results First Posted Date  ICMJE May 11, 2017
Last Update Posted Date May 11, 2017
Actual Study Start Date  ICMJE June 3, 2013
Actual Primary Completion Date June 7, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2013)
Overall Response Rate of Participants [ Time Frame: 3.5 years ]
The primary objective is to show improvement of the overall response rate from the current standard of 40% with chemotherapy alone, to 70% with the addition of LDFRT, in patients with recurrent unresectable head and neck squamous cell carcinoma.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2013)
  • Number of Participants Experiencing Adverse Events [ Time Frame: 3.5 years ]
    Assess the safety profile (acute and late toxicities) of the proposed treatment
  • Progression-Free Survival [ Time Frame: 3.5 years ]
  • Overall Survival [ Time Frame: 3.5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma
Official Title  ICMJE Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Squamous Cell Carcinoma
  • Head and Neck Cancer
  • Recurrent Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Erbitux, Taxotere, LD Fractionated RT
Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)
Interventions:
  • Drug: Erbitux
  • Drug: Taxotere
  • Radiation: Low Dose Fractionated Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 8, 2016)
5
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2013)
35
Actual Study Completion Date  ICMJE June 7, 2016
Actual Primary Completion Date June 7, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01794845
Other Study ID Numbers  ICMJE 20090467
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Matthew Abramowitz, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew C Abramowitz, MD University of Miami
PRS Account University of Miami
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP