Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)
Overview
- Phase
- Phase 1
- Intervention
- Taxotere
- Conditions
- Head and Neck Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Dose Limiting Toxicity
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Roy B. Tishler, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •Pathology:
- •- Histologic documentation of squamous cell carcinoma of the head and neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc.).
- •- 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:
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.
Arms & Interventions
Taxotere
* 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: Taxotere
Taxotere
* 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: Surgery
Taxotere
* 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: radiation therapy
Outcomes
Primary Outcomes
Dose Limiting Toxicity
Time Frame: 8 Weeks
MTD of Taxotere
Time Frame: 8 Weeks
Secondary Outcomes
- Overall Response Rate(4-12 weeks post chemo/radiation therapy)
- Tumor Resistance Predictors(Up to 1 year post chemo/radiation therapy)