Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00226239
Recruitment Status : Completed
First Posted : September 26, 2005
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 22, 2005
First Posted Date  ICMJE September 26, 2005
Results First Submitted Date  ICMJE January 15, 2016
Results First Posted Date  ICMJE July 11, 2017
Last Update Posted Date July 11, 2017
Study Start Date  ICMJE October 2005
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2017)
Objective Response Rate (ORR) [ Time Frame: Up to 36 months ]
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2005)
To evaluate the objective response rate with induction with cisplatin/docetaxel/cetuximab in subjects.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2017)
  • Objective Response Rate (ORR) [ Time Frame: Up to 36 months ]
    Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
  • Progression-free Survival (PFS) [ Time Frame: Up to 36 months ]
    PFS is an estimated percentage of participants without disease progression at two years (or three years) after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0. The two-year and three-year PFS ended up being the same in this study.
  • 2-year Overall Survival (OS) [ Time Frame: Up to 24 months ]
    Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.
  • 3-year Overall Survival (OS) [ Time Frame: Up to 36 months ]
    Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.
  • Quality of Life (QOL) [ Time Frame: Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE ]
    Effect of treatment on acute and late QOL and functional status using Functional Assessment of Cancer Therapy-General (FACT-G) with FACT-Head and Neck (FACT-HN) subscale. The instructions to the participant were: "Below is a list of statements that other people with your illness have said are important. By circling one number per line, please indicate how true each statement has been for you during the past 7 days." The choices for each statement ranged from 0 (not at all) to 4 (very much). The FACT-G and FACT-Head and Neck total scores were computed by summing 27 and 39 questions respectively, for four subscales: physical well-being, social well-being, emotional well-being, and functional well-being. Questions for both assessments are phrased so that higher numbers/values indicate a better health state.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2005)
To evaluate the toxicities, objective response rate post chemoradiotherapy, time to progression, overall survival, local and distant failure rates.
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2017)
EGFR-related Serum Markers [ Time Frame: Up to 36 months ]
Evaluation of changes in serum markers (EGFR-related) before and after therapy in the above patient population, and expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer
Official Title  ICMJE A Phase II Trial of Docetaxel, Cetuximab (C225), and Cisplatin Followed by Radiation, Cetuximab, and Cisplatin in Locally Advanced Head and Neck Cancer
Brief Summary The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.
Detailed Description

This research study involves the use of a combination of two chemotherapies, cisplatin and docetaxel, which have been known to shrink head and neck cancers and are a commonly used treatment for this type of cancer. This combination will then be followed by radiation and more chemotherapy.

The purpose of this study is to see whether this combination of chemotherapy and radiation, with the addition of Cetuximab, can improve control of disease and collect information on what side effects this combination therapy may have. In addition, biologic factors (markers) will be studied that may help to predict and treat head and neck cancer patients in the future.

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 Cancer
Intervention  ICMJE
  • Drug: Docetaxel
    Docetaxel 75 mg/m^2 IV over 1 hour, day 1
  • Drug: Cisplatin
    Cisplatin 75 mg/m^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.
  • Drug: Cetuximab
    Cetuximab dose will be 250 mg/m^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3).
    Other Name: (Erbitux or C225)
  • Procedure: Radiation Therapy
    Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies>6 MV may be utilized when appropriate to boost target localized centrally.
Study Arms  ICMJE Experimental: Head and neck cancer patients
Induction chemotherapy consists of 3 cycles of cisplatin 75 mg/m^2, on day 1, docetaxel 75 mg/m^2, on day 1, and cetuximab weekly days 1,8,15, repeated every 21 days (cetuximab dose is 400 mg/m^2 on day 1 and 250 mg/m^2 on subsequent weekly treatments). After 3 cycles of induction, patients receive standard radiation 70 Gy/200 cGy/daily, 5 days/week with concurrent weekly cisplatin 30 mg/m^2 and cetuximab 250 mg/m^2. After completing radiation therapy, patients receive cetuximab weekly as maintenance therapy for 6 months (see section 5 for detailed treatment plan and dose modifications)
Interventions:
  • Drug: Docetaxel
  • Drug: Cisplatin
  • Drug: Cetuximab
  • Procedure: Radiation Therapy
Publications * Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23. Review.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2013)
39
Original Enrollment  ICMJE
 (submitted: September 22, 2005)
40
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Stage III-IVB head and neck cancer, all sites, including unknown primary tumors (bulky stage II (T2N0) lesions of the base of tongue or hypopharynx and patients with stage II nasopharyngeal cancer are also eligible) Prior to study entry the resectability and alternative treatment options will be determined by a team composed of an Ear, Nose, and Throat Surgeon, a Radiation Oncologist and a Medical Oncologist. Stage determination, optimal local treatment, and its timing according to this protocol will be determined at this evaluation. Unequivocal demonstration of distant metastasis (M1) confers ineligibility
  2. Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas, or WHO types I-III of the nasopharynx
  3. Unidimensionally-measurable disease is required (RECIST)
  4. No prior chemotherapy, biologic/molecular targeted therapy (including any prior therapy which specifically and directly targets the EGFR pathway), or radiotherapy for head and neck cancer
  5. Prior surgical therapy will consist only of incisional or excisional biopsy and organ sparing procedures such as debulking of airway compromising tumors or neck dissection in a patient with an existing primary tumor (Any non-biopsy procedure must have taken place > 4 weeks but < 3 months of initiating protocol treatment)
  6. ECOG PS 0 or 1; 7. Organ & marrow function per protocol criteria and 8. Age of >=18 years

Exclusion Criteria:

  1. History of severe allergic reactions attributed to docetaxel or compounds of similar chemical or biologic composition to docetaxel, or other drugs formulated with polysorbate 80
  2. Uncontrolled intercurrent illness or significant history of uncontrolled cardiac disease
  3. Receiving any other investigational agents
  4. No history of prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, or malignancy that has been treated with a curative intent with a 5-year disease-free survival
  5. Significant baseline sensory or motor neurologic deficits (> grade I neuropathy); 6. HIV-positive patients and 7. Prior severe infusion reaction to a monoclonal antibody.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT00226239
Other Study ID Numbers  ICMJE 05-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Julie Bauman, MD Univ of Pittsburgh
PRS Account University of Pittsburgh
Verification Date April 2017

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