Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck

NCT00392665 | Terminated Phase 2 Results

• 1 other identifier: 06-111
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this research study is to collect information to learn how effective erlotinib (tarceva) is in combination with either bevacizumab or sulindac in treating patients with squamous cell carcinoma of the head and neck. Erlotinib and bevacizumab are targeted therapy drugs that can control tumor growth by targeting specific abnormalities sometimes found on cancer cells. Erlotinib targets epidermal growth factor receptor (EGFR), and bevacizumab targets vascular endothelial growth factor (VEGF). Sulindac is a non-steroidal anti-inflammatory drug (NSAID) that can block G protein-coupled receptor which laboratory evidence shows is associated with both cancer cell growth and EGFR activity. The bevacizumab being administered in this study is not a commercially marketed formulation of the drug. Previous research with head and neck cancer suggest that erlotinib alone has some anti-cancer activity. This research study is designed to see how well erlotinib works in combination with bevacizumab or sulindac in head and neck cancer.

Conditions

Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Keywords

SCCHN; erlotinib; tarceva

Outcome Measures

Primary Outcomes (1)

• Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival.

  The primary outcome will be measured by median progression-free survival (PFS), determined by the Kaplan-Meier method for both Arm A and Arm B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  1 year

Secondary Outcomes (3)

• Overall Response Rate (ORR)

  2 years

• Duration of Overall Survival

  2 years

• Number of Participants With Toxicities According to Severity

  2 years

Study Arms (2)

Erlotinib + Bevacizumab

ACTIVE COMPARATOR

erlotinib plus bevacizumab

Drug: Bevacizumab; Drug: erlotinib

Erlotinib + Sulindac

ACTIVE COMPARATOR

erlotinib plus sulindac

Drug: erlotinib; Drug: Sulindac

Interventions

Bevacizumab DRUG

Given intravenously on day one of each 3 week cycle

Erlotinib + Bevacizumab

erlotinib DRUG

Given orally once a day

Also known as: Tarceva

Erlotinib + Bevacizumab; Erlotinib + Sulindac

Sulindac DRUG

Given orally twice a day

Erlotinib + Sulindac

Eligibility Criteria

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

You may qualify if:

• Histologically/cytologically documented SCCHN, excluding salivary gland primary sites
• years of age or older
• Have evaluable locoregional and/or metastatic disease according to RECIST that is not appropriate for treatment by primary surgical resection or radiotherapy
• Have locoregional and/or metastatic disease that has failed to respond to or relapsed from at least one prior chemotherapy or chemoradiotherapy
• Life expectancy of at least 4 months
• ECOG performance status of 0-2
• Use of effective means of contraception in patients of child-bearing potential

You may not qualify if:

• Other malignancy within 5 years except non-melanomatous skin cancer, or carcinoma in situ of the cervix, bladder or head and neck
• Concurrent anticancer therapy other than that of this study
• Treatment with any anticancer drug within 28 days of day 1
• Radiotherapy within 28 days of day 1
• Any unresolved toxicity greater than NCI-CTCAE v 3.0 grade 2 from prior systemic anticancer therapy
• Any prior therapy that targets the ErbB and/or VEGF pathways
• Concurrent therapy with any NSAID
• Known hypersensitivity characterized by acute bronchospasm, urticaria and/or rhinitis to NSAIDs, including aspirin
• Serum creatinine \> 1.5 x ULN
• Abnormal LFTs as outlined in protocol
• Blood pressure \> 150/100mmHg
• Active unstable angina, or myocardial infarction within 6 months
• NYHA Grade II or greater congestive heart failure
• History of stroke within 6 months
• Clinically significant active peripheral vascular disease

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Emory University: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Genentech, Inc.: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Bevacizumab; Erlotinib Hydrochloride; Sulindac

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Lori J. Wirth, MD
• Organization: Massachusetts General Hospital

LWIRTH@mgh.harvard.edu

617-724-4000

Study Officials

• Jochen Lorch, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2006
• First Posted: October 26, 2006
• Study Start: October 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 13, 2017
• Results First Posted: March 14, 2017

Record last verified: 2017-03

Locations

US (2)