Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity

Stopped early · Phase 2

Conditions studied: Oropharyngeal Neoplasms

In brief

This study looks at the use of three cycles of chemotherapy given prior to radiation therapy in patients with cancer of the oral cavity and evidence of prior exposure to Human Papilloma Virus (HPV). Patients with cancer of the oral cavity who have evidence of exposure to HPV have a better prognosis than those who do not have such evidence of exposure to HPV. The main hypothesis of this study is that using three cycles of chemotherapy prior to embarking on radiation therapy will allow the use of reduced doses of radiation therapy and, therefore, less radiation induced side-effects. The primary objective is to determine the activity of this pre-radiation chemotherapy strategy along with reduced dose levels of radiation with or without chemotherapy during the radiation phase. The effectiveness of the strategy will be assessed at three months following the completion of the radiation therapy phase and also at two years following completion of the radiation therapy.

Key facts

Study ID

NCT01525927

Run by

Northwell Health

People needed

2

Starts

2010-08-01

Expected to finish

2011-12-01

Last updated by the study team

2017-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Tumor tissue available from primary or nodal metastasis for histological analysis.
• High p16 tumor expression by IHC, or indeterminate p16 expression by IHC and definitively positive detection of high-risk HPV infection by ISH.
• T-stage = T1-3 or post-tonsillectomy Tx (T1-3).
• N-stage = N1-2 or Nx (N1-2).
• Biopsy-confirmed oropharyngeal primary site.
• Histology = squamous cell carcinoma, basaloid-squamous carcinoma, nasopharyngeal-type squamous carcinoma, adenosquamous carcinoma, or papillary squamous carcinoma.
• Age > 17 years old.
• Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC at least 1500 cells/mm3 and platelet count at least 100,000 cells/mm3); adequate hepatic function with bilirubin less than 1.5x ULN (excluding Gilbert's disease); SGOT, SGPT and alkaline phosphatase must be within the normal range to be eligible for study.
• Creatinine clearance at least 70 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) x (wt in kg)/serum Cr x 72; CrCl female = 0.85 x (CrCl male).
• Patients must have an untransfused hemoglobin of at least 9.0 grams/dL.
• Patients should have no serious acute or chronic co-morbid condition, or acute infection, which in the judgment of the attending physician would affect administration of the induction chemotherapy regimens.
• Patients must sign a study-specific informed consent form.
• All of the above lab criteria must be verified within 28days of registration.

You may not qualify if…

• Low p16 expressing tumor by IHC, or indeterminate p16 expression by IHC and negative or weak detection of high-risk HPV infection by ISH.
• TxNx without residual measurable disease, T4, or N3 disease.
• Significant cigarette smoking history, defined as >10 pack-years total lifetime exposure. Pack years is calculated as # packs smoked per day x # years smoking.
• Histology other than squamous cell carcinoma.
• Proven distant metastases (below the clavicle) by clinical or radiographic measures.
• Karnofsky performance status < 80 or ECOG >1.
• Prior chemotherapy, within the previous 3 years.
• Prior radiotherapy to the head and neck.
• Initial surgical resection rendering the patient clinically and radiologically disease free.
• Simultaneous primary invasive cancers, excluding superficial non-melanoma skin cancers.
• Patients with a history of another malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free).
• Men and women of childbearing potential (WOCBP) unwilling to consent to using effective contraception while on treatment and for at least 3 months thereafter. Note: WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for 3 months after the study in such a manner that the risk of pregnancy is minimized.

Where it is running

• Long Island Jewish Medical Center — New Hyde Park, New York, United States

Full record on ClinicalTrials.gov

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