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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech
OSI Pharmaceuticals
Information provided by (Responsible Party):
Southern Illinois University
ClinicalTrials.gov Identifier:
NCT00304278
First received: March 16, 2006
Last updated: June 12, 2014
Last verified: June 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • Change in largest diameter of tumor lesion using RECIST criteria [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response and progression post treatment [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: March 2006
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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:
No publications provided

Responsible Party: Southern Illinois University
ClinicalTrials.gov Identifier: NCT00304278     History of Changes
Other Study ID Numbers: RAO-OSI-3601S, Genentech, Inc.
Study First Received: March 16, 2006
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014