A single arm feasibility study of Metronomic Chemotherapy(etoposide plus methotrexate + celecoxib- ETOMEC) in Advanced, Inoperable, and Metastatic Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To determine the objective response rate (ORR) to oral etoposide, methotrexate and celecoxib combination in the locally advanced, inoperable, and metastatic head and neck cancer patients.
研究概览
简要总结
Metronomic chemotherapy defined as the frequent administration of drug doses designed to maintain a low but active range of concentrations of chemotherapeutic agents during prolonged periods of time without inducing excessive toxicities. This includes a 2-drug regimen of methotrexate and celecoxib with a response rate of 12-13% in head and neck cancers.
We hypothesize that a combination of oral etoposide, methotrexate and celecoxib can lead to an improvement in the response rate from 12-25% in patients with locally advanced, inoperable and metastatic squamous cell carcinoma of head and neck region
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with histologically or cytologically confirmed squamous cell carcinoma of the head and neck region
- •Locally advanced or metastatic tumor unsuitable for loco-regional therapy (involvement of skull base, prevertebral fascia, major vessels, gross mandibular erosion, oro-cutaneous fistula, or extensive disease which cannot be safely encompassed in radiation field).
- •Palliative radiation for pain relief is acceptable.
- •Patients who have taken prior lines of therapies are included provided they have a documented progression.
- •Age 18 years to 80 years.
- •Eastern Cooperative Oncology Group performance status 0, 1,
- •Measurable disease as defined by response evaluation criteria in solid tumors (version 1.1) (7)
- •Adequate bone marrow function: Absolute Neutrophil Count (ANC) more than 1,500, platelets more than 100,000, hemoglobin more than 8 g)
- •Creatinine clearance using Cockroft Gault formula more than 45 ml/min
- •Adequate hepatic function: bilirubin less than 1.5 x UNL SGOT PT less than 30 or below the reference range of the lab
- •Adequate cardiac function as decided by clinical examination.
- •Women should use contraceptive medication for 6 months after the end of the study or she would be post-menopause status.
- •Men should consent with the contraception for 6 months after the end of the study or he would be infertile.
- •Have financial constraints for immunotherapy or cetuximab based therapy
- •Patients should sign a written informed consent before study entry.
排除标准
- •Histologic types other than squamous cell or the primaries in the thyroid, salivary glands and nasopharynx should be excluded.
- •2.Decompensated, cardiac, pulmonary, renal, immunological disease, psychiatric illness, active tuberculosis and those seropositive for HIV, HBV and HCV not on treatment.
- •Those who have received methotrexate or etoposide in the prior lines of therapy or on celecoxib for any other reason.
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception.
结局指标
主要结局
To determine the objective response rate (ORR) to oral etoposide, methotrexate and celecoxib combination in the locally advanced, inoperable, and metastatic head and neck cancer patients.
时间窗: response evaluation to be done after completion of | 4 cycles | 8 cycles | 12 cycles
次要结局
- Clinical benefit rate (CBR) of this regimen(Progression free survival (PFS) of this regimen)
研究者
Deepak Sundriyal
All Indi Institute of Medical Sciences