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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00226239
First received: September 22, 2005
Last updated: July 23, 2013
Last verified: July 2013

September 22, 2005
July 23, 2013
October 2005
July 2013   (final data collection date for primary outcome measure)
To evaluate the objective response rate with induction with cisplatin/docetaxel/cetuximab in subjects. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
To evaluate the objective response rate with induction with cisplatin/docetaxel/cetuximab in subjects.
Complete list of historical versions of study NCT00226239 on ClinicalTrials.gov Archive Site
To evaluate the toxicities, objective response rate post chemoradiotherapy, time to progression, overall survival, local and distant failure rates. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
To evaluate the toxicities, objective response rate post chemoradiotherapy, time to progression, overall survival, local and distant failure rates.
Not Provided
Not Provided
 
Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer
A Phase II Trial of Docetaxel, Cetuximab (C225), and Cisplatin Followed by Radiation, Cetuximab, and Cisplatin in Locally Advanced Head and Neck Cancer

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
  • Drug: Docetaxel
    Docetaxel 75 mg/m2 IV over 1 hour, day 1
  • Drug: Cisplatin
    Cisplatin 75 mg/m2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.
  • Drug: Cetuximab
    Cetuximab dose will be 250 mg/m2 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.
Experimental: Single Arm study
Induction chemotherapy consists of 3 cycles of cisplatin 75 mg/m2, on day 1, docetaxel 75 mg/m2, on day 1, and cetuximab weekly days 1,8,15, repeated every 21 days (cetuximab dose is 400 mg/m2 on day 1 and 250 mg/m2 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/m2 and cetuximab 250 mg/m2. After completing radiation, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00226239
05-003
Yes
University of Pittsburgh
University of Pittsburgh
Bristol-Myers Squibb
Principal Investigator: Julie Bauman, MD Univ of Pittsburgh
University of Pittsburgh
July 2013

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