NCT02363829已完成1 期
A Phase I Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)
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
- 6
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
Patients 18 years of age and older with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical carcinoma limited to the pelvis will receive twice daily oral nelfinavir (NFV) and weekly IV cisplatin in combination as radiosensitizers with daily whole pelvic external beam and intracavitary radiation brachytherapy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients with primary, previously untreated, histologically confirmed invasive carcinoma of the uterine cervix (any cell type). Clinical stages IIA, IIB, IIIA, IIIB, IVA. A representative H & E stained slide showing documentation of the primary invasive cancer is required.
- •Patients must have adequate bone marrow, renal and hepatic function:
- •Laboratory work must be performed within 30 days prior to start of study treatment.
- •ANC ≥ 1,500/μL; Platelet count ≥ 100,000/μL; Creatinine < 2.0 mg/dL; Total Bilirubin ≤ 1.5 times normal; SGOT ≤ 3 times normal.
- •Patients with a ECOG/GOG Performance Status of 0, 1, or
- •Patients with ureteral obstruction must be treated with stent or nephrostomy tube.
- •Patients of childbearing potential must use an effective form of birth control."Patients receiving oral contraceptives should be instructed that alternate or additional contraceptive measures should be used during therapy with VIRACEPT. "
- •Confirmed seronegative HIV status within 3 months prior to start of study treatment.
- •Patients must be at least 18 years of age.
- •Patients must have signed an approved informed consent and authorization permitting release of personal health information.
- •Exclusion criteria
- •Patients with Stage IA, IB or IVB disease.
- •Patients who have known metastases to other organs outside the radiation field at the time of the original clinical and surgical staging.
- •Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy.
- •Patients with septicemia or severe infection.
- •Patients who have circumstances that will not permit completion of this study or the required follow-up.
- •Patients who are pregnant at the time of diagnosis and do not wish pregnancy termination prior to initiation of treatment.
- •Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields.
- •Patients with other concomitant malignancies (with the exception of non-melanoma skin cancer), who had (or have) any evidence of other cancer present within the last 5 years.
- •Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
- •Patients with poorly controlled diabetes mellitus despite medication.
- •Patients taking anti-arythmic agents such as amiodarone, quinidine, rifampin, ergot derivatives such as ergotamine, St John's Wort, HMG-CoA reductase inhibitors such as lovastatin, neuroleptic such as pimozide, sedatives such as midazolam and triazolam among other CYP3A4 and CYP2C19 substrates.
- •Patients with Phenylketonuria
排除标准
- 未提供
研究组 & 干预措施
Treatment
Experimental
Nelfinavir and Cisplatin
干预措施: Nelfinavir (Drug)
Treatment
Experimental
Nelfinavir and Cisplatin
干预措施: Cisplatin (Biological)
结局指标
主要结局
Number of Adverse Events
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by SurgeryStage II Vulvar Cancer AJCC v8Stage III Vulvar Cancer AJCC v8Stage IIIA Vulvar Cancer AJCC v8Stage IIIB Vulvar Cancer AJCC v8Stage IIIC Vulvar Cancer AJCC v8Stage IVA Vulvar Cancer AJCC v8NCT04169763M.D. Anderson Cancer Center25
终止
3 期
A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical CancerCervical NeoplasmsNCT00190528Haruhiko Fukuda200
已完成
1 期
Safety Study of Nelfinavir + Cisplatin + Pelvic Radiation Therapy to Treat Cervical CancerCervical CancerNCT01485731University of Miami8
已完成
1 期
A Phase I Trial of Nelfinavir (Viracept ) in Adults With Solid TumorsSolid TumorsNCT01445106National Cancer Institute (NCI)28
撤回
2 期
A Phase II Single-arm Intervention Trial of Nelfinavir in Patients With Grade 2/3 or 3 Cervical Intraepithelial NeoplasiaCervical DysplasiaNCT01925378The University of Texas Health Science Center, Houston