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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304278
First Posted: March 17, 2006
Last Update Posted: July 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Genentech, Inc.
OSI Pharmaceuticals
Information provided by (Responsible Party):
Southern Illinois University
  Purpose
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

Condition Intervention Phase
Head and Neck Cancer Drug: Erlotinib (Tarceva) Drug: Intra-arterial Cisplatin (PLAT) Radiation: Radiation Therapy (RAD) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)

Resource links provided by NLM:


Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • Number of Participants With Complete and Partial Response Using RECIST Criteria [ Time Frame: 17 weeks ]
    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 [ Time Frame: 22 months ]
    Overall Survival with a minimum follow up of 1year. Relapse/Persistent Disease Rates


Enrollment: 21
Study Start Date: March 2006
Study Completion Date: December 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RADPLAT and Tarceva

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

Drug: Erlotinib (Tarceva)
150 mg daily X 7 weeks
Other Name: Tarceva
Drug: Intra-arterial Cisplatin (PLAT)
1 dose (150 mg/sq) per week X 4 weeks
Other Name: Cisplatin
Radiation: Radiation Therapy (RAD)
5 days per week X 7 weeks

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304278


Locations
United States, Illinois
Simmons Cooper Cancer Institute/SIU School of Medicine
Springfield, Illinois, United States, 62702
Sponsors and Collaborators
Southern Illinois University
Genentech, Inc.
OSI Pharmaceuticals
Investigators
Principal Investigator: Krishna Rao, MD, PhD SIU School of Medicine
Principal Investigator: Thomas Robbins, MD Simmons Cancer Institute at SIU
  More Information

Additional Information:
Responsible Party: Southern Illinois University
ClinicalTrials.gov Identifier: NCT00304278     History of Changes
Other Study ID Numbers: RAO-OSI-3601S
Genentech, Inc.
First Submitted: March 16, 2006
First Posted: March 17, 2006
Results First Submitted: November 2, 2016
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017
Last Verified: June 2017

Keywords provided by Southern Illinois University:
Head and Neck Cancer
Erlotinib
RADPLAT

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action