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

Primary Purpose

Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Erbitux,merck serono

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma focused on measuring tongue, Squamous cell carcinoma, locally advanced, cetuximab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

Rabin Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cetuximab ,neoadjuvant administration

Arm Description

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

Outcomes

Primary Outcome Measures

PROGRESSION FREE SURVIVAL

: 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

Secondary Outcome Measures

Adverse event rate

To evaluate the frequency and severity of adverse events (AEs) for this treatment paradigm.

Biomarker prediction

To evaluate the correlation between changes in expression levels of several biomarkers related to cell apoptosis and tumor progression: the endothelial growth factor receptor pathway, p53, human papilloma virus, BCL-2, BCL-X(L), and acid ceramidase - before and after treatment - with survival rates, PFS and response rates

Full Information

NCT ID

NCT01760811

First Posted

January 2, 2013

Last Updated

January 2, 2013

Sponsor

Rabin Medical Center

Collaborators

Kaplan Medical Center, Meir Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01760811

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rabin Medical Center

Collaborators

Kaplan Medical Center, Meir Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma

Keywords

tongue, Squamous cell carcinoma, locally advanced, cetuximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cetuximab ,neoadjuvant administration

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Erbitux,merck serono

Intervention Description

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

Primary Outcome Measure Information:

Title

PROGRESSION FREE SURVIVAL

Description

Time Frame

2 YEARS

Secondary Outcome Measure Information:

Title

Adverse event rate

Description

To evaluate the frequency and severity of adverse events (AEs) for this treatment paradigm.

Time Frame

2 years

Title

Biomarker prediction

Description

Time Frame

2 years

Other Pre-specified Outcome Measures:

Title

Micro -RNA

Description

To evaluate the role of downregulation of microRNAs according to the outcome of treatment

Time Frame

2 YEARS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aron Popovtzer, MD

Phone

9729739378004

aronp@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Dror Limon, MD

Phone

9729378004

drorl@clalt.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aron Popovtzer, MD

Organizational Affiliation

Tel Aviv University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rabin Medical Center

City

Petah Tiqva

ZIP/Postal Code

49100

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aron Popovtzer, MD

Phone

9729378044

aronp@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Dror Limon, MD

First Name & Middle Initial & Last Name & Degree

Salomon Stemmer, MD

First Name & Middle Initial & Last Name & Degree

Rafael Feinmesser, MD

First Name & Middle Initial & Last Name & Degree

Thomas Spitzer, MD

First Name & Middle Initial & Last Name & Degree

Gideon Bachar, MD

First Name & Middle Initial & Last Name & Degree

Aron Popovtzer, MD

12. IPD Sharing Statement

Learn more about this trial

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

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