Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) of Participants
研究概览
简要总结
Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.
详细描述
The investigator's approach is based on the following reasons:
- Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest.
- LDFRT will render enhanced bax activation mediated mode of cell death.
- Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death.
- The toxicity profile is expected to be minimal.
Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract .Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥ 6 months following the end of the prior RT.
- •The recurrence must have defined bi- or uni-dimensional measurements.
- •Recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence).
- •The patient must not be a candidate for surgical resection.
- •Patients must be at least 6 months from completion of prior chemotherapy and radiation therapy.
- •Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum bilirubin ≤ 1.5 mg/dl, creatinine < 1.5 mg/dl within 3 weeks prior to registration.
- •Liver Function Tests (LFTs) ≤ 2 x normal (serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic-pyruvic transaminase (SGPT)/Alkaline Phosphatase). If > 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
- •Patients must sign a study-specific informed consent form prior to study entry.
排除标准
- •Distant metastases outside of the head and neck.
- •Primary disease in the nasopharynx or the salivary gland.
- •Other concurrent invasive malignancies.
- •Prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are permissible).
- •Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
- •Pre-existing grade ≥ 2 peripheral sensory neuropathy
- •Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
- •Prior history of sever hypersensitivity reaction to Docetaxol, Cetuximab or a drug with formulated with Polysorbate 80.
研究组 & 干预措施
Erbitux, Taxotere, LD Fractionated RT
Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)
干预措施: Erbitux (Drug)
Erbitux, Taxotere, LD Fractionated RT
Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)
干预措施: Taxotere (Drug)
Erbitux, Taxotere, LD Fractionated RT
Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)
干预措施: Low Dose Fractionated Radiation Therapy (Radiation)
结局指标
主要结局
Overall Response Rate (ORR) of Participants
时间窗: Up to 6 months from End of Treatment, about 9 months
ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.
次要结局
- Estimated Progression-Free Survival (PFS)(Up to 6 years)
- Number of Study Participants Experiencing Treatment-Related Toxicity(Up to 6 years)
- Estimated Overall Survival (OS)(Up to 6 years)
研究者
Matthew Abramowitz
Assistant Professor of Clinical
University of Miami