Status:
TERMINATED
Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity
Lead Sponsor:
Northwell Health
Conditions:
Oropharyngeal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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). P...
Detailed Description
Induction Chemotherapy TPF induction chemotherapy will be administered as published from the TAX 323 phase III trial. Specifically, each cycle will consist of docetaxel at a dose of 75 mg per square m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01525927
Start Date
August 1 2010
End Date
December 1 2011
Last Update
December 19 2017
Active Locations (1)
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1
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040