Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | Allocation: Non-Randomized 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) |
- Change in largest diameter of tumor lesion using RECIST criteria [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]
- Response and progression post treatment [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]
- Various toxicities [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 21 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
-
Drug: Erlotinib (Tarceva)
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 |
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| United States, Illinois | |
| Simmons Cooper Cancer Institute/SIU School of Medicine | |
| Springfield, Illinois, United States, 62702 | |
| Principal Investigator: | Krishna Rao, MD, PhD | SIU School of Medicine |
| Principal Investigator: | K Thomas Robbins, MD | SimmonsCooper Cancer Institute at SIU |
More Information
Additional Information:
No publications provided
| Responsible Party: | Krishna Rao, M.D., Ph.D., Simmons Cooper Cancer Institute - SIU School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00304278 History of Changes |
| Other Study ID Numbers: | RAO-OSI-3601S, Genentech, Inc. |
| Study First Received: | March 16, 2006 |
| Last Updated: | July 22, 2011 |
| 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 May 16, 2013