Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity
This study is currently recruiting participants.
Verified February 2012 by North Shore Long Island Jewish Health System
Sponsor:
Bhoomi Mehrotra
Information provided by (Responsible Party):
Bhoomi Mehrotra, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01525927
First received: February 1, 2012
Last updated: February 2, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Oropharyngeal Neoplasms |
Drug: Docetaxel Drug: Cisplatin Drug: Flourouracil Radiation: External beam radiation therapy/ Intensity modulated RT Drug: Carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Neoadjuvant Chemotherapy for HPV-Associated Squamous Cell Carcinoma of the Oropharynx Followed by Reduced Dose Radiotherapy/Chemoradiotherapy for Responders or Standard Dose Chemoradiotherapy for Non-Responders |
Resource links provided by NLM:
Further study details as provided by North Shore Long Island Jewish Health System:
Primary Outcome Measures:
- Response (CR+PR) status at 3 months post-therapy [ Time Frame: 3 months following completion of radiation phase ] [ Designated as safety issue: No ]The 3-month response rate will be estimated using standard methods for estimating proportions and their 95% one-sided confidence intervals (CIs). Comparison to the historical control data will be carried out using a chi-square test for comparing proportions (or a Fisher exact test if an expected cell frequency in the 2x2 table is less than 5).
Secondary Outcome Measures:
- To define objective tumor response rates to induction chemotherapy and to subsequent radiation-based treatment, per RESIST version 1.1 criteria. [ Time Frame: Three months following completion of radiation therapy phase. ] [ Designated as safety issue: No ]To define objective tumor response rates to induction chemotherapy and to subsequent radiation-based treatment, per RESIST version 1.1 criteria.
- To assess progression-free survival at 2 years [ Time Frame: At two years following completion of radiation phase ] [ Designated as safety issue: No ]Progression-free survival at 2 years.
- To assess overall survival at 2 years. [ Time Frame: At two years following completion of radiation phase ] [ Designated as safety issue: No ]To assess overall survival at 2 years.
- To assess locoregional disease control at 2 years [ Time Frame: At two years following completion of radiation phase ] [ Designated as safety issue: No ]To assess locoregional disease control at 2 years
- 3.5 To assess distant disease control at 2 years. [ Time Frame: At two years following completion of radiation phase ] [ Designated as safety issue: No ]3.5 To assess distant disease control at 2 years.
- Assessment of quality of life outcomes [ Time Frame: Baseline, during therapy and up to two years following completion of radiation phase ] [ Designated as safety issue: No ]Serial evaluation of functional quality-of-life, including M. D. Anderson Dysphagia Inventory (MDADI) and Oropharyngeal swallowing efficiency (OPSE) measures of swallowing function, as well as formal sialometric measurement of parotid function.
- To identify additional toxicity of treatment [ Time Frame: During therapy and up to 5 years following completion of treatment ] [ Designated as safety issue: Yes ]To identify additional toxicity of treatment
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Docetaxel
- FU
- 5-Flourouracil
- 5FU
- RT
- Chemo-RT
- IMRT
75mg/M2 on day one of each 21 day cycle times 3 cycles during neoadjuvant chemotherapy phase.
Other Name: Taxotere
Drug: Cisplatin
75mg/M2 on day one of each 21 day cycle times 3 cycles during neoadjuvant chemotherapy phase.
Other Name: Platinol
Drug: Flourouracil
750 mg/M2 per day by continuous intravenous infusion on days 1-5 of every 21 day cycle times 3 cycles during neoadjuvant chemotherapy phase.
Other Names:
Radiation: External beam radiation therapy/ Intensity modulated RT
Daily treatments on weekdays (5 days per week) for total of 6 weeks. May be given with or without concommitent chemotherapy using cisplatin or carboplatin. Decision to be made by treating oncologist.
Other Names:
Drug: Cisplatin
35 mg/M2 by IV infusion weekly times 6 weeks during radiation therapy phase.
Other Name: Platinol
Drug: Carboplatin
AUC 1.5 by IV infusion weekly times 6 weeks during radiation therapy phase.
Other Name: Paraplatin
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525927
Contacts
| Contact: Bhoomi Mehrotra, MD | (718)470-8934 | mehrotra@lij.edu |
Locations
| United States, New York | |
| Long Island Jewish Medical Center | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Ann Way, RN 718-470-4469 away@lij.edu | |
| Contact: Jason Light, MS, MPH (718)470-4050 jlight@nshs.edu | |
| Principal Investigator: Bhoomi Mehrotra, MD | |
Sponsors and Collaborators
Bhoomi Mehrotra
Investigators
| Principal Investigator: | Bhoomi Mehrotra, MD | North Shore-LIJ Health System |
More Information
Publications:
| Responsible Party: | Bhoomi Mehrotra, Associate Chief for Oncology, North Shore-LIJ Department of Medicine, North Shore Long Island Jewish Health System |
| ClinicalTrials.gov Identifier: | NCT01525927 History of Changes |
| Other Study ID Numbers: | NSLIJ0844 |
| Study First Received: | February 1, 2012 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by North Shore Long Island Jewish Health System:
|
Oropharyngeal Neoplasms Neoplasms, Oropharyngeal Oropharynx Neoplasms |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma, Squamous Cell Oropharyngeal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site |
Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Docetaxel Cisplatin Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013