CTRI/2016/04/006834尚未招募1 期
â??Stage I/II study of oral metronomic methotrexate with celecoxib and erlotinib as palliative chemotherapy in oral cancer patientsâ??
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Histologically proven squamous cell cancers of oral cavity with at least one measurable lesion.
- •2.Age > 18 years
- •3.ECOG PS 0 - 2
- •4.No uncontrolled comorbidities
- •5.Not affording cetuximab based chemotherapy
排除标准
- •1.Participants who are receiving any other investigational agents.
- •2.Patients with history of aspiration pneumonia or who are unable to swallow tablets
- •3.Primary sites of malignancy in major salivary gland or nasopharynx or skin
- •4.Patients receiving methotrexate for other indications not limited to rheumatoid arthritis
- •5.Patients who had received long term Cox-2 inhibitors ( more than 3 month continuous usage) will be excluded
- •6.Patients with hypercalcemia at presentation (defined as a corrected serum calcium of > 10.5 mg/dL).
- •7.Patients with QTc prolongation defined as QTc interval greater than 440 ms in males and 480 ms in females in view of risk of sudden cardiac death associated with use of celecoxib.
- •8.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
- •9.Uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease, known hyperkalemia ( CTCAE version 4.02 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements.
- •10.Pregnant women and breastfeeding women are excluded from this study because celecoxib / erlotinib and methotrexate are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants. These potential risks may also apply to other agents used in this study.
- •11.HIV-positive, Hepatitis B and C seropositive patients are excluded from this study.
- •12.Patients with previous history of other cancers.
研究者
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