Study to Assess Biomarkers in Patients With Resectable Oral Cavity Cancer Randomized to Receive Preoperative Treatment

2014-08-27 03:13:58 | BioPortfolio


The objective of this study is to assess the biological effects in the primary tumor following a short, pre-operative course of treatment with PF-00298804 in patients with Oral Cavity Cancer.


This is a single-center, randomized, double-blinded, biomarker driven, preoperative window of opportunity study with a pharmacodynamic primary endpoint. Patients with resectable, histologically confirmed OCC for whom surgical treatment is planned as definitive management, will be randomized 2:1 to receive PF-00299804 pre-operatively at a loading dose of 45 mg twice daily orally for 3 days, followed by 5 days of dosing at 45 mg once daily orally (plus or minus 3 days depending on surgery schedule), or to Matching Placebo for 8 days (plus or minus 3 days depending on surgery schedule). The target is a total of 8 days of treatment but with a minimum of 5 and a maximum of 11 dosing days. All patients will receive surgery as per standard of care without delay. Biomarkers from the surgical specimen and mandatory baseline tumor biopsy will be evaluated for primary and secondary pharmacodynamic endpoints.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Oral Cavity Cancer




Princess Margaret Hospital
M5G 2M9




University Health Network, Toronto

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:58-0400

Clinical Trials [1769 Associated Clinical Trials listed on BioPortfolio]

PF-00299804 As A Single Oral Agent In Untreated Adenocarcinoma Of The Lung In Non-Smokers Or Former Light Smokers

This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (

Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer

This study will investigate the safety and efficacy of oral PF-00299804 in patients who have not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck squam...

PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma

There are three arms to this study (A, B and C) The purpose of this research study during Arm A is to see how much of PF-00299804 gets into the brain tumor. For many brain tumors, one rea...

Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors

The primary purpose of this study is to study the side effects of PF-00299804 and determine the highest dose that can be safely administered in patients with advanced cancer.

PF-00299804 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Standard Therapy for Advanced or Metastatic Cancer

RATIONALE: PF-00299804 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether PF-00299804 is more effective than a placebo i...

PubMed Articles [18513 Associated PubMed Articles listed on BioPortfolio]

Changing prognosis of oral cancer: An analysis of survival and treatment between 1973 and 2014.

Oral cavity cancer is the most commonly occurring malignancy of the head and neck. There are limited data suggesting a change in prognosis of oral cavity cancers. We aimed to evaluate temporal trends ...

Does anatomic subsite influence oral cavity cancer mortality? A SEER database analysis.

To determine if there are differences in mortality from oral cavity squamous cell carcinoma (OCSCC) based on oral cavity (OC) subsites.

The pathology of oral cancer.

The term 'oral cancer' describes a range of malignancies that may arise in and around the oral cavity. Over 90% of such lesions are squamous cell carcinomas, but even these may be divided into differe...

Imaging patients with cancer of the oral cavity.

The staging of oral cavity tumours as with all other malignancy subsites is undergoing a revision in the line with the updated American Joint Committee on Cancer guidelines. Of note, the new guideline...

Evaluation of early oral cavity cancer treatment quality at a single institution.

To evaluate the adherence to oral cavity quality guidelines endorsed by the American Head and Neck Society (AHNS) at a large tertiary care hospital.

Medical and Biotech [MESH] Definitions

The oval-shaped oral cavity located at the apex of the digestive tract and consisting of two parts: the vestibule and the oral cavity proper.

Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)

Uptake of substances into the body via the mucosal surfaces (MUCOUS MEMBRANE) of the oral cavity.

A dental specialty concerned with pathology of the oral cavity.

A hereditary disease characterized by multiple ectodermal, mesodermal, and endodermal nevoid and neoplastic anomalies. Facial trichilemmomas and papillomatous papules of the oral mucosa are the most characteristic lesions. Individuals with this syndrome have a high risk of BREAST CANCER; THYROID CANCER; and ENDOMETRIAL CANCER. This syndrome is associated with mutations in the gene for PTEN PHOSPHATASE.

More From BioPortfolio on "Study to Assess Biomarkers in Patients With Resectable Oral Cavity Cancer Randomized to Receive Preoperative Treatment"

Quick Search


Relevant Topics

Biological Therapy
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body&rs...

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Searches Linking to this Trial