CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment in Locally Advanced Tongue Cancer ; A NEW PARADIGM OF TREATMENT

CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment Followed by 6 Weeks of Cetuximab+RT Post Surgery in Locally Advanced Squamous Cell Carcinoma of the Tongue ; A NEW PARADIGM OF TREATMENT

Sponsors

Lead Sponsor: Rabin Medical Center

Collaborator: Kaplan Medical Center
Meir Medical Center

Source Rabin Medical Center
Brief Summary

To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501 and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and cisplatin) with a similar stage of the disease.

Detailed Description

This non-randomized, open-label, single center phase II study, will determine if patients with advanced oral tongue cancer that are treated with induction doses of cetuximab followed by treatment with radiation therapy concurrently with cetuximab and cisplatin (when indicated by positive margins or extra-capsular extension), will have improved PFS and improved survival and feasible toxicity, compared with patients treated in previous clinical trials (RTOG 9501 and EORTC 22931) with standard therapy: radiotherapy of 60 Gy with or without a 6-Gy boost (RTOG 9501) or 66 Gy (EORTC 22931) delivered through a conventional fractionation regimen of five once-daily sessions per week, and cisplatin in a dose of 100 mg/m2 on days 1, 22, and 43.. Twenty five patients will be recruited. Cetuximab treatment will be started (day 0) with 400 mg/m2 followed by two doses of 250 mg/m2 (once weekly on day 7 and 14). Surgery will be performed on day 31 followed by treatment with radiation therapy concurrently with cetuximab (250 mg/m2, once weekly) and cisplatin 35 mg/m2 (days 70-112; when indicated by positive margins or lymph nodes with extra-capsular extension). PET-CT and biopsies will be performed before starting with cetuximab, just before surgery and after chemo-cetuximab-RT to determine efficacy of treatment, and to compare the diagnostic properties of the PET-CT with that of the biopsies. The changes, before and after treatment with cetuximab, of protein levels in saliva, and tumor tissue and of microRNA levels in tumor tissue will be studied and correlated with PFS. The quality of life will be assessed. Data from clinical trials RTOG 9501 and EORTC 22931 will be used as historical controls.

Overall Status Unknown status
Start Date January 2013
Completion Date December 2017
Primary Completion Date December 2015
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
PROGRESSION FREE SURVIVAL 2 YEARS
Secondary Outcome
Measure Time Frame
Adverse event rate 2 years
Biomarker prediction 2 years
Enrollment 25
Condition
Intervention

Intervention Type: Drug

Intervention Name: Erbitux,merck serono

Description: cetuximab loading dosage 400mg/m2 followed by weekly 250mg/m2 2 weeks

Arm Group Label: Cetuximab ,neoadjuvant administration

Eligibility

Criteria:

Inclusion Criteria:

Pathologically confirmed, previously untreated, resectable squamous cell carcinoma of the tongue at disease stage III or IV; Age ≥18 to ≤80; Eastern Cooperative Oncology Group (ECOG) Performance status 0-1;willingto give written informed consent for participation in this study -

Exclusion Criteria:

Any prior head and neck malignancy or other malignancy in the last 5 years but BCC; Prior head and neck radiation; Documented evidence of distant metastases; Pregnancy or lactation; Clinically significant cardiovascular disease; Known hypersensitivity to any of the components of the treatment; Legal incapacity; Clinically relevant neuropathy; Any medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment, or interfere with the study objectives. -

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Aron Popovtzer, MD Principal Investigator Tel Aviv University
Overall Contact

Last Name: Aron Popovtzer, MD

Phone: 9729739378004

Email: [email protected]

Location
Facility: Contact: Investigator: Rabin Medical Center Aron Popovtzer, MD 9729378044 [email protected] Dror Limon, MD Sub-Investigator Salomon Stemmer, MD Sub-Investigator Rafael Feinmesser, MD Sub-Investigator Thomas Spitzer, MD Sub-Investigator Gideon Bachar, MD Sub-Investigator Aron Popovtzer, MD Principal Investigator
Location Countries

Israel

Verification Date

January 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Rabin Medical Center

Investigator Full Name: popovtzer aron

Investigator Title: Head of head and neck cancer unit

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Cetuximab ,neoadjuvant administration

Type: Other

Description: Drug administration ,Cetuximab(merck Serono )given neoadjuvant ,3 courses prior surgery followed by post operatve radiation and Cetuximab

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov