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

• ClinicalTrials.gov Identifier: NCT00304278
• Recruitment Status: Completed
• First Posted: March 17, 2006
• Results First Posted: July 27, 2017
• Last Update Posted: July 27, 2017
• Sponsor: Southern Illinois University
• Collaborators: Genentech, Inc.; OSI Pharmaceuticals
• Information provided by (Responsible Party): Southern Illinois University

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

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

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: N/A
• 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)
• Study Start Date: March 2006
• Actual Primary Completion Date: May 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. Survival Post Treatment [ Time Frame: 22 months ]
   Overall Survival with a minimum follow up of 1year. Relapse/Persistent Disease Rates

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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:

official website of the SimmonsCooper Cancer Institute at SIU 

• Responsible Party: Southern Illinois University
• ClinicalTrials.gov Identifier: NCT00304278
• Other Study ID Numbers: RAO-OSI-3601S; Genentech, Inc.
• First Posted: March 17, 2006
• 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; Squamous Cell Carcinoma of Head and Neck; 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