Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
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).
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).
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in largest diameter of tumor lesion using RECIST criteria
Outcome Time Frame:
17 weeks
Safety Issue:
Yes
Principal Investigator
Krishna Rao, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
SIU School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
RAO-OSI-3601S
NCT ID:
NCT00304278
Start Date:
March 2006
Completion Date:
August 2012
Related Keywords:
- Head and Neck Cancer
- Head and Neck Cancer
- Erlotinib
- RADPLAT
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Simmons Cooper Cancer Institute/SIU School of Medicine | Springfield, Illinois 62702 |
