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Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib (Tarceva)
Intra-arterial Cisplatin (PLAT)
Radiation Therapy (RAD)
Sponsored by
Southern Illinois University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, Erlotinib, RADPLAT

Eligibility Criteria

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

Inclusion Criteria: Patients must have histologically or cytologically confirmed Stage III-IV disease comprised of T3 or T4 N0-2 lesions of the oral cavity, oropharynx, hypopharynx, and larynx. No previous radiation therapy or chemotherapy. No evidence of distant metastatic disease. Age > 18. Karnofsky performance status of > 60 (ECOG 2). ANC > 1000, platelets > 100,000, calculated or 24-hour creatinine clearance > 60. Study-specific informed consent form. Protocol treatment must begin < 8 weeks of diagnostic biopsy. Ability to understand and the willingness to sign a written informed consent document. Patients with surgically cured secondary malignancy who have been disease free > 5 years are eligible. Exclusion Criteria: Radiologic evidence of bone destruction. Previous or concurrent head and neck primaries. Prior surgery to study site other than biopsy. Patients receiving any other investigational agents. History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant women are excluded from this study because treatments and agents have the potential for teratogenic or abortifacient effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. History of a prior or concomitant malignancy (other than carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin).

Sites / Locations

  • Simmons Cooper Cancer Institute/SIU School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RADPLAT and Tarceva

Arm Description

All patients will receive RADPLAT and Tarceva: Drug: Erlotinib (Tarceva) 150 mg daily X 7 weeks Other Names: Tarceva Drug: Intra-arterial Cisplatin (PLAT) 1 dose (150 mg/sq) per week X 4 weeks Other Names: Cisplatin Radiation: Radiation Therapy (RAD) 5 days per week X 7 weeks

Outcomes

Primary Outcome Measures

Number of Participants With Complete and Partial Response Using RECIST Criteria
Complete and Partial Response as defined by RECIST 1.0. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD

Secondary Outcome Measures

Survival Post Treatment
Overall Survival with a minimum follow up of 1year. Relapse/Persistent Disease Rates

Full Information

First Posted
March 16, 2006
Last Updated
June 27, 2017
Sponsor
Southern Illinois University
Collaborators
Genentech, Inc., OSI Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00304278
Brief Title
Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
Official Title
Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern Illinois University
Collaborators
Genentech, Inc., OSI Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and effectiveness of treatment with Tarceva (Erlotinib) and RADPLAT (RADiation and intraarterial cisPLATin) for patients with Head and Neck cancer
Detailed Description
Head and neck malignancies represent a group of epidermoid tumors that arise from the epithelial lining of the mouth, pharynx, and larynx. Three modalities of therapy have established roles in the treatment of carcinoma of the head and neck: chemotherapy, radiation therapy (XRT), and surgery. The choice of modality depends upon many factors such as the site and extent of the primary lesion, the likelihood of complete surgical resection, the presence of lymph node metastases, etc. Traditionally, smaller lesions (stage T1-T2) are effectively treated either, by surgical excision or irradiation whereas more advanced disease (stage III-IV) is treated with combined surgery and XRT. The subsequent morbidity related to extensive surgery is a major problem among survivors. Clearly, there is a need to develop therapeutic strategies for patients with advanced head and neck cancer with more effective approaches employing non-surgical modalities. Our hypothesis is that head and neck cancers are resistant to apoptosis from DNA damage induced by radiation and chemotherapy. This resistance is mediated by EGFR overexpression which results in downstream activation of cell survival signals, such as AKT, and may be overcome when Erlotinib (Tarceva) is co-administered with RADiation and cisPLATin (intraarterial chemotherapy).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Head and Neck Cancer, Erlotinib, RADPLAT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RADPLAT and Tarceva
Arm Type
Experimental
Arm Description
All patients will receive RADPLAT and Tarceva: Drug: Erlotinib (Tarceva) 150 mg daily X 7 weeks Other Names: Tarceva Drug: Intra-arterial Cisplatin (PLAT) 1 dose (150 mg/sq) per week X 4 weeks Other Names: Cisplatin Radiation: Radiation Therapy (RAD) 5 days per week X 7 weeks
Intervention Type
Drug
Intervention Name(s)
Erlotinib (Tarceva)
Other Intervention Name(s)
Tarceva
Intervention Description
150 mg daily X 7 weeks
Intervention Type
Drug
Intervention Name(s)
Intra-arterial Cisplatin (PLAT)
Other Intervention Name(s)
Cisplatin
Intervention Description
1 dose (150 mg/sq) per week X 4 weeks
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy (RAD)
Intervention Description
5 days per week X 7 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Complete and Partial Response Using RECIST Criteria
Description
Complete and Partial Response as defined by RECIST 1.0. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
Time Frame
17 weeks
Secondary Outcome Measure Information:
Title
Survival Post Treatment
Description
Overall Survival with a minimum follow up of 1year. Relapse/Persistent Disease Rates
Time Frame
22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have histologically or cytologically confirmed Stage III-IV disease comprised of T3 or T4 N0-2 lesions of the oral cavity, oropharynx, hypopharynx, and larynx. No previous radiation therapy or chemotherapy. No evidence of distant metastatic disease. Age > 18. Karnofsky performance status of > 60 (ECOG 2). ANC > 1000, platelets > 100,000, calculated or 24-hour creatinine clearance > 60. Study-specific informed consent form. Protocol treatment must begin < 8 weeks of diagnostic biopsy. Ability to understand and the willingness to sign a written informed consent document. Patients with surgically cured secondary malignancy who have been disease free > 5 years are eligible. Exclusion Criteria: Radiologic evidence of bone destruction. Previous or concurrent head and neck primaries. Prior surgery to study site other than biopsy. Patients receiving any other investigational agents. History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant women are excluded from this study because treatments and agents have the potential for teratogenic or abortifacient effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. History of a prior or concomitant malignancy (other than carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krishna Rao, MD, PhD
Organizational Affiliation
SIU School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Robbins, MD
Organizational Affiliation
Simmons Cancer Institute at SIU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simmons Cooper Cancer Institute/SIU School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.siumed.edu/cancer/
Description
official website of the SimmonsCooper Cancer Institute at SIU

Learn more about this trial

Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)

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