Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 8
- 主要终点
- Patient Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.
详细描述
OBJECTIVES:
- Evaluate the efficacy of irinotecan hydrochloride and cisplatin in patients with local-regionally recurrent or metastatic squamous cell carcinoma of the head and neck.
- Evaluate the toxicity of irinotecan hydrochloride and cisplatin in these patients.
- Determine the palliative effect of irinotecan hydrochloride and cisplatin on head and neck cancer symptoms using the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey.
OUTLINE: Patients receive irinotecan hydrochloride IV over 60 minutes and cisplatin IV on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey at baseline, before each course, at the completion of study therapy, and then at each follow-up visit.
After completion of study therapy, patients are followed every 6 weeks for 1 year and then every 3 months thereafter.
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
- •Histologically confirmed squamous cell carcinoma of the head and neck that is considered incurable with surgery or radiotherapy
- •Meets one of the following criteria:
- •Previously untreated disease
- •Newly diagnosed disease with distant metastases
- •Recurrent or persistent disease
- •Local-regional recurrence/persistence or distant metastases after initial treatment with surgery or radiotherapy
- •No locally advanced unresectable disease that was not previously treated with radiotherapy
- •Bidimensionally measurable disease
- •If the only measurable disease is within the radiotherapy port, there must be biopsy-proven recurrence ≥ 8 weeks after the completion of radiotherapy
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Creatinine clearance ≥ 50 mL/min
- •SGOT ≤ 3 times upper limit of normal
- •Serum bilirubin < 1.5 mg/dL
- •Granulocytes ≥ 1,500/mm ^3
- •Platelet count > 100,000/mm^3
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No significant detectable infection
- •No co-morbid disease unless under adequate control
- •No other cancer within the past 3 years except basal cell or squamous cell skin cancer or early-stage prostate cancer
排除标准
- •Pregnant or lactating women
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from any prior major surgery
- •No prior chemotherapy for recurrent or metastatic disease
- •Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy ≥ 3 months prior to recurrence will be considered chemotherapy-naive
- •Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy < 3 months prior to recurrence will be considered chemotherapy failures
- •No prior therapy with topotecan or irinotecan hydrochloride
- •At least 4 weeks since prior biologic therapy (e.g., interleukin-2, interferon, megestrol acetate)
研究组 & 干预措施
Therapeutic Intervention
干预措施: cisplatin (Drug)
Therapeutic Intervention
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Patient Response
时间窗: 6 weeks after last chemotherapy treatment
Number of patients in each response category according to RECIST criteria: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
次要结局
- Number of Patients With Each Worst-grade Toxicity(6 weeks after last chemotherapy)
研究者
Barbara Murphy, MD
Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center