NCT00006107已完成1 期
Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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.
排除标准
- •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
- •- 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.
研究组 & 干预措施
Taxotere
Experimental
- 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
干预措施: Taxotere (Drug)
Taxotere
Experimental
- 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
干预措施: Surgery (Procedure)
Taxotere
Experimental
- 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
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: 8 Weeks
MTD of Taxotere
时间窗: 8 Weeks
次要结局
- Overall Response Rate(4-12 weeks post chemo/radiation therapy)
- Tumor Resistance Predictors(Up to 1 year post chemo/radiation therapy)
研究者
Roy B. Tishler, MD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (2)
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