Status:
WITHDRAWN
Phase II Study of Cetuximab With or Without OSI-906 in Head and Neck Squamous Cell Carcinoma (HNSCC)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
OSI Pharmaceuticals
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if the addition of OSI-906 to cetuximab can improve response. The safety of these drugs will also be studied. Objectives: Primary Objective(s): T...
Detailed Description
Cetuximab is designed to prevent or slow down the growth of cancer cells by blocking proteins on the cancer cell, called the epidermal growth factor receptor (EGFR). OSI-906 is designed to prevent or...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx.
- Patients must be willing to have a biopsy of tumor tissue for biomarker analysis.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>/= 20 mm with conventional techniques or as \>/= 10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI). Measurable lymph nodes are required to be \>/= 15 mm in size (short axis diameter). Measurable disease in previously radiated areas is acceptable as long as there has been documented progression.
- Patients must have disease progression: 1) After platinum-based chemotherapy for recurrent/metastatic disease OR 2) Within 6 months of receiving definitive platinum-based combined modality therapy.
- Previous treatment with cetuximab is allowed, as long as there has been a period \>/= 6 months between the last cetuximab treatment and randomization
- All prior cytotoxic therapy must have been completed at least three weeks prior to treatment on study.
- Age \>/= 18 years
- ECOG performance status \</= 2 or Karnofsky \>/= 60%
- Patients must have normal liver function as defined below: total bilirubin \</= institutional upper limit of normal and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) \</= 2.5 \* institutional upper limit of normal.
- Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
- Patients must provide verbal and written informed consent to participate in this study
- Prior radiation treatment is acceptable as long as it has been completed one week prior to treatment on protocol.
Exclusion
- Patients may not be receiving any other investigational agents with anti-cancer activity.
- Patients with known, untreated brain metastases. Patients with treated (irradiated or resected) brain metastases are eligible if treatment was completed \>/= 28 days prior to study entry and if clinical neurologic function is stable.
- History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-906 or other agents used in the study.
- QTc interval \> 450 msec at baseline.
- Concomitant drugs with a generally accepted risk of causing Torsades de Pointes
- Congestive heart failure, New York Heart Association (NYHA) Class III or IV
- History of arrhythmia which is symptomatic and requires treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled on medication are not excluded.
- Fasting blood sugar \> 150 mg/dl at baseline
- Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.
- Pregnant or breast-feeding females.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01427205
Start Date
June 1 2013
Last Update
April 5 2013
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