Phase II Study of Cetuximab With or Without OSI-906 in Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT01427205 | Withdrawn Phase 2 DMC

• 1 other identifier: 2010-0680
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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): To assess progression-free survival (PFS) among patients with head and neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab plus OSI-906 and compare it with PFS among patients treated with cetuximab plus placebo. Secondary Objective(s):

• To assess the safety and toxicity of these treatment regimens.
• To assess the efficacy of these two treatment regimens in terms of overall survival, response rate, and disease control rate
• To assess the efficacy of single agent OSI-906 following cetuximab treatment in terms of response rate and disease control rate in patients who cross-over from Arm B to receive single-agent OSI-906
• To explore blood-based and tissue biomarkers

Conditions

Head and Neck Cancer

Keywords

Head and Neck Squamous Cell Carcinoma; HNSCC; recurrent; metastatic; oral cavity; Cetuximab; C225; Erbitux; IMC-C225; OSI-906; Placebo; sugar pill; oropharynx; larynx; hypopharynx

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is time to progressive disease or death of any cause from randomization date, assessed every 6 weeks with a total study period of approximately 24 months.

  From treatment initiation to progressive disease or death, up to 24 months for study period.

Study Arms (2)

Group A: Cetuximab + OSI-906

EXPERIMENTAL

Cetuximab loading dose of 400 mg/m2 by vein (IV) then 250 mg/m2 weekly + OSI-906 150 mg orally twice a day. 21-Day Cycle.

Drug: Cetuximab; Drug: OSI-906

Group B: Cetuximab + Placebo

EXPERIMENTAL

Cetuximab loading dose of 400 mg/m2 by vein (IV) then 250 mg/m2 weekly + Placebo orally twice a day. 21-Day Cycle.

Drug: Cetuximab; Other: Placebo

Interventions

Cetuximab DRUG

Loading dose 400 mg/m2 by vein once followed by 250 mg/m2 weekly (+/- 7 days).

Also known as: C225, Erbitux, IMC-C225

Group A: Cetuximab + OSI-906; Group B: Cetuximab + Placebo

OSI-906 DRUG

150 mg by mouth twice a day.

Group A: Cetuximab + OSI-906

Placebo OTHER

Placebo taken by mouth twice daily.

Also known as: sugar pill

Group B: Cetuximab + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• OSI Pharmaceuticals: collaborator

Related Links

• UT MD Anderson Website

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Recurrence; Neoplasm Metastasis; Laryngeal Diseases

Interventions

Cetuximab; 3-(8-amino-1-(2-phenylquinolin-7-yl)imidazo(1,5-a)pyrazin-3-yl)-1-methylcyclobutanol; Sugars

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Carbohydrates

Study Officials

• William N. William Jr., MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 1, 2011
• Study Start: June 1, 2013
• Primary Completion: June 1, 2016
• Last Updated: April 5, 2013

Record last verified: 2013-04