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Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC2008-03 TPEx


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Squamous Cell Head and Neck Carcinoma, Recurrent or Metastatic Disease

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Trial Information

Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC2008-03 TPEx


OBJECTIVES:

Primary

- To determine the efficacy of TPEx combination in patients with head and neck cancer in
term of objective response rate (RECIST, see statistical consideration) Secondary

- To assess toxicities of TPEx combination

- Determine the efficacy of TPEx combination in patients with head and neck cancer: Best
Overall Response , progression-free survival and survival.

- Translational research objective:To better understand the mechanisms of chemoresistance
and to identify biomarkers by the analysis of the tumor biopsies (RNA, gene expression
profile) and protein profile (plasma samples). Exploratory analyses.

OUTLINE: This is an open-label phase II, multicenter study. Patients receive four cycles of
chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2
hours on day 1. Treatment repeats every 21 days in the absence of disease progression or
unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients
receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued
until disease progression or unacceptable toxicities according to the patient or the
investigator. Tumor check-up will be performed every 6 weeks. This study will allow
translational research with blood sample and biopsies at baseline before any treatment,
during the treatment with TPEx combination (week 6).,After completion of study treatment,
patients are followed every 2 months.


Inclusion Criteria:



- Histologically proven squamous cell carcinoma of the oral cavity, larynx, oropharynx
or hypopharynx

- Recurrent disease, incurable disease as determined by surgery or radiation, or
metastatic disease

- Measurable or evaluable disease

- Age > 18 years and <= 70 years

- WHO performance status 0 or 1

- Absolute neutrophil count > 1,500/mm3

- Platelets > 150,000/mm3

- Total Bilirubin <= institutional upper limit of normal

- Aspartate aminotransferase < 1.5 X institutional upper limit of normal

- Alanine aminotransferase < 1.5 X institutional upper limit of normal

- Alkaline phosphatase < 2.5 X institutional upper limit of normal

- creatinine clearance > 60 mL/min

- Signed informed consent

- Women of child-bearing potential and men must be willing and able practice adequate
contraception prior to study entry and for the duration of study treatment

Exclusion Criteria:

- Previous chemotherapy. Chemotherapy given as part of initial curative therapy and
completed more than 6 months before inclusion is allowed

- Previous treatment with total doses of cisplatin > 300 mg/ m2

- Patients must not have any co-existing disease that would preclude cisplatin
administration, such as peripheral neuropathy or renal failure

- Surgery (excluding biopsy) or radiotherapy within 4 weeks prior to study entry

- Nasopharyngeal carcinoma, or cancer of sinusal cavities

- Active infection including tuberculosis or HIV positive patient

- Other malignancy within last 5 years except for non-melanoma skin cancer

- No other investigational agent within 30 days prior to study entry

- No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy
(excluding contraceptives and replacement steroids), radiotherapy, or experimental
medications

- No prior anti EGFR therapy

- No known brain metastases

- Uncontrolled intercurrent illness that would prevent delivery of protocol therapy

- Patients with a prior history of basal cell carcinoma of the skin or in situ
carcinoma of the cervix must have been curatively treated and must have remained
disease free for 5 years post diagnosis

- No history of hypersensitivity reaction to drugs on study

- No unstable angina or myocardial infarction within the past 12 months

- No symptomatic congestive heart failure or New York Heart Association (NYHA) class
II-IV heart disease

- No serious uncontrolled cardiac arrhythmia

- No other prior or concomitant squamous cell carcinoma

- No other prior or concomitant cancer, except curatively treated basal carcinoma of
the skin or in situ cervical cancer, for which the patient has been curatively
treated and remains disease-free for the past 5 years

- Patient is pregnant or lactating

- Patients must not have any co-existing condition that would preclude full compliance
with the study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

objective tumor response rate

Outcome Description:

The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria

Outcome Time Frame:

12 weeks (after completion of the fourth cycle of chemotherapy)

Safety Issue:

No

Principal Investigator

Joel GUIGAY

Investigator Role:

Study Chair

Investigator Affiliation:

GORTEC

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GORTEC2008-03TPex

NCT ID:

NCT01289522

Start Date:

September 2009

Completion Date:

December 2013

Related Keywords:

  • Squamous Cell Head and Neck Carcinoma
  • Recurrent or Metastatic Disease
  • Squamous cell carcinoma of the head and neck
  • recurrent or metastatic
  • first line chemotherapy
  • cetuximab
  • docetaxel
  • cisplatin
  • antineoplastic agents
  • First Line Palliative Treatment
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Neoplasm Metastasis

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