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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01427205
First received: August 30, 2011
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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

Condition Intervention Phase
Head and Neck Cancer
Drug: Cetuximab
Drug: OSI-906
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of Cetuximab With or Without OSI-906, a Dual Insulin-like Growth Factor-1 Receptor and an Insulin Receptor Inhibitor, in Platinum-Refractory, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: From treatment initiation to progressive disease or death, up to 24 months for study period. ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: June 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: Cetuximab + OSI-906
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
Loading dose 400 mg/m2 by vein once followed by 250 mg/m2 weekly (+/- 7 days).
Other Names:
  • C225
  • Erbitux
  • IMC-C225
Drug: OSI-906
150 mg by mouth twice a day.
Experimental: Group B: Cetuximab + Placebo
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
Loading dose 400 mg/m2 by vein once followed by 250 mg/m2 weekly (+/- 7 days).
Other Names:
  • C225
  • Erbitux
  • IMC-C225
Other: Placebo
Placebo taken by mouth twice daily.
Other Name: sugar pill

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx.
  2. Patients must be willing to have a biopsy of tumor tissue for biomarker analysis.
  3. 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.
  4. 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.
  5. Previous treatment with cetuximab is allowed, as long as there has been a period >/= 6 months between the last cetuximab treatment and randomization
  6. All prior cytotoxic therapy must have been completed at least three weeks prior to treatment on study.
  7. Age >/= 18 years
  8. ECOG performance status </= 2 or Karnofsky >/= 60%
  9. 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.
  10. 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.
  11. Patients must provide verbal and written informed consent to participate in this study
  12. Prior radiation treatment is acceptable as long as it has been completed one week prior to treatment on protocol.

Exclusion Criteria:

  1. Patients may not be receiving any other investigational agents with anti-cancer activity.
  2. 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.
  3. History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-906 or other agents used in the study.
  4. QTc interval > 450 msec at baseline.
  5. Concomitant drugs with a generally accepted risk of causing Torsades de Pointes
  6. Congestive heart failure, New York Heart Association (NYHA) Class III or IV
  7. History of arrhythmia which is symptomatic and requires treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled on medication are not excluded.
  8. Fasting blood sugar > 150 mg/dl at baseline
  9. Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.
  10. Pregnant or breast-feeding females.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427205

Sponsors and Collaborators
M.D. Anderson Cancer Center
OSI Pharmaceuticals
Investigators
Principal Investigator: William N. William Jr., MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01427205     History of Changes
Other Study ID Numbers: 2010-0680
Study First Received: August 30, 2011
Last Updated: April 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Squamous Cell Carcinoma
HNSCC
recurrent
metastatic
oral cavity
Cetuximab
C225
Erbitux
IMC-C225
OSI-906
Placebo
sugar pill
oropharynx
larynx
hypopharynx

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
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014