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Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Taxotere
Surgery
radiation therapy
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, salivary gland squamous cell carcinoma, recurrent lymphoepithelioma of the nasopharynx, recurrent lymphoepithelioma of the oropharynx, stage III lymphoepithelioma of the nasopharynx, stage III lymphoepithelioma of the oropharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV lymphoepithelioma of the oropharynx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pathology: -- Histologic documentation of squamous cell carcinoma of the head and neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc.). Stage: -- Patients will be entered on this protocol after initial induction therapy, if, prior to the induction regimen, they were previously untreated Stage III or IV (MO) SCCHN. Evaluable disease during induction therapy is required. Required Prior Therapy: Patients entered on this protocol will have received platinum/FUra based induction chemotherapy. They may have received a taxane as part of this plan. Patients treated with induction are eligible provided that they receive no more than 3 cycles of chemotherapy, but at least one cycle of chemotherapy, and are less then 7 weeks from the start of last cycle of induction therapy. Other Malignancies: Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥2 years prior to study entry. Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. Other Prior Therapy: Patients treated with induction therapy Hormonally treated patients are eligible. Performance: Patients must meet the following performance criteria: Performance status: ≤2 (ECOG) Complete recovery from previous diagnostic or therapeutic procedures is required. Nutritional Status: Adequate and nutritionally balanced enteral intake ≥ 1,800 kcal/day). A PEG is required prior to initiation of radiation. Age: ≥18 years Life Expectancy: Longer than 3 months. Women of child bearing potential must not be pregnant by history or lactating at the time of entry on this protocol and men and women of child bearing potential must be requested to use an accepted and effective method of birth control during therapy. Organ Function: Biochemical and hematological parameters (obtained within 2 weeks of study entry) as follows: Hepatic: SGOT < 1.5 x ULN and Alkaline Phosphatase < 2.5 x ULN for entry. Total Bilirubin = WNL and SGOT must be ≤ 2 x ULN as an isolated value. SGPT ≤ 2.5 x ULN Hematologic: WBC ≥ 3,000/mm3 or a normal absolute neutrophil count (ANC) ≥ 1000; Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 10 gm/d1 (transfusion to bring the hemoglobin to or above this level is permitted if clinically indicated, however, transfusions should not be used solely in order to meet eligibility criteria). Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2. Other: Lack of other serious illness or medical condition Informed consent: -- Patients must give written informed consent. Follow-up: All patients must be available for monthly evaluation and re-staging by the physicians from the Head and Neck Cancer Clinic while on therapy. Exclusion Criteria: Pathology: -- Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥ 2 years prior to study entry. Other Malignancies: Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. Other Prior Therapy: Patients who were previously treated with radiotherapy for SCCHN are not eligible. Patients treated with any form of prior chemotherapy, other than induction therapy within the last 5 years are not eligible Performance: Nutritional Status: Patients requiring intravenous alimentation as primary source of calories are excluded from this study. Patients with persistent diarrhea are ineligible. Organ Function: -- Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2. -- Cardiovascular/Pulmonary: No acute cardiac dysrhythmias or unstable cardiac condition such as angina. Follow-up: Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 will be excluded.

Sites / Locations

  • Massachusetts General Hospital
  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Taxotere

Arm Description

Taxotere: (1 hour infusion once a week for four weeks) Radiation Therapy (5 days/week for 6-7 weeks) Surgery (if required) 14 -12 weeks after radiotherapy Follow-up

Outcomes

Primary Outcome Measures

MTD of Taxotere
Dose Limiting Toxicity

Secondary Outcome Measures

Overall Response Rate
Tumor Resistance Predictors
Tumor Biopsies and tissues

Full Information

First Posted
August 3, 2000
Last Updated
June 15, 2017
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006107
Brief Title
Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Official Title
Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 14, 2000 (Actual)
Primary Completion Date
July 17, 2003 (Actual)
Study Completion Date
July 3, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy. Determine the toxicity of this treatment regimen in this patient population. Determine the efficacy of this treatment regimen in these patients. OUTLINE: This is a dose escalation study of docetaxel. Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy alone twice daily for 2 weeks. Upon completion of chemoradiotherapy, patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy. Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. Additional patients are treated at the MTD. Patients are followed monthly for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, salivary gland squamous cell carcinoma, recurrent lymphoepithelioma of the nasopharynx, recurrent lymphoepithelioma of the oropharynx, stage III lymphoepithelioma of the nasopharynx, stage III lymphoepithelioma of the oropharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV lymphoepithelioma of the oropharynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taxotere
Arm Type
Experimental
Arm Description
Taxotere: (1 hour infusion once a week for four weeks) Radiation Therapy (5 days/week for 6-7 weeks) Surgery (if required) 14 -12 weeks after radiotherapy Follow-up
Intervention Type
Drug
Intervention Name(s)
Taxotere
Other Intervention Name(s)
Docetaxel
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
MTD of Taxotere
Time Frame
8 Weeks
Title
Dose Limiting Toxicity
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Overall Response Rate
Time Frame
4-12 weeks post chemo/radiation therapy
Title
Tumor Resistance Predictors
Description
Tumor Biopsies and tissues
Time Frame
Up to 1 year post chemo/radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathology: -- Histologic documentation of squamous cell carcinoma of the head and neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc.). Stage: -- Patients will be entered on this protocol after initial induction therapy, if, prior to the induction regimen, they were previously untreated Stage III or IV (MO) SCCHN. Evaluable disease during induction therapy is required. Required Prior Therapy: Patients entered on this protocol will have received platinum/FUra based induction chemotherapy. They may have received a taxane as part of this plan. Patients treated with induction are eligible provided that they receive no more than 3 cycles of chemotherapy, but at least one cycle of chemotherapy, and are less then 7 weeks from the start of last cycle of induction therapy. Other Malignancies: Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥2 years prior to study entry. Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. Other Prior Therapy: Patients treated with induction therapy Hormonally treated patients are eligible. Performance: Patients must meet the following performance criteria: Performance status: ≤2 (ECOG) Complete recovery from previous diagnostic or therapeutic procedures is required. Nutritional Status: Adequate and nutritionally balanced enteral intake ≥ 1,800 kcal/day). A PEG is required prior to initiation of radiation. Age: ≥18 years Life Expectancy: Longer than 3 months. Women of child bearing potential must not be pregnant by history or lactating at the time of entry on this protocol and men and women of child bearing potential must be requested to use an accepted and effective method of birth control during therapy. Organ Function: Biochemical and hematological parameters (obtained within 2 weeks of study entry) as follows: Hepatic: SGOT < 1.5 x ULN and Alkaline Phosphatase < 2.5 x ULN for entry. Total Bilirubin = WNL and SGOT must be ≤ 2 x ULN as an isolated value. SGPT ≤ 2.5 x ULN Hematologic: WBC ≥ 3,000/mm3 or a normal absolute neutrophil count (ANC) ≥ 1000; Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 10 gm/d1 (transfusion to bring the hemoglobin to or above this level is permitted if clinically indicated, however, transfusions should not be used solely in order to meet eligibility criteria). Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2. Other: Lack of other serious illness or medical condition Informed consent: -- Patients must give written informed consent. Follow-up: All patients must be available for monthly evaluation and re-staging by the physicians from the Head and Neck Cancer Clinic while on therapy. Exclusion Criteria: Pathology: -- Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥ 2 years prior to study entry. Other Malignancies: Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. Other Prior Therapy: Patients who were previously treated with radiotherapy for SCCHN are not eligible. Patients treated with any form of prior chemotherapy, other than induction therapy within the last 5 years are not eligible Performance: Nutritional Status: Patients requiring intravenous alimentation as primary source of calories are excluded from this study. Patients with persistent diarrhea are ineligible. Organ Function: -- Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2. -- Cardiovascular/Pulmonary: No acute cardiac dysrhythmias or unstable cardiac condition such as angina. Follow-up: Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy B. Tishler, MD, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

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