A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 20
- 主要终点
- Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
研究概览
简要总结
This phase II trial is studying the side effects of gemcitabine and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the antitumor activity of gemcitabine hydrochloride in patients with persistent or recurrent endometrial adenocarcinoma who have failed higher priority treatment protocols.
II. To determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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
- •Histologically confirmed endometrial adenocarcinoma
- •Recurrent or persistent disease
- •Refractory to curative therapy or established treatments
- •The following epithelial cell types are eligible:
- •Endometrioid adenocarcinoma
- •Serous adenocarcinoma
- •Undifferentiated carcinoma
- •Clear cell adenocarcinoma
- •Mixed epithelial carcinoma
- •Adenocarcinoma not otherwise specified
- •Mucinous adenocarcinoma
- •Squamous cell carcinoma
- •Transitional cell carcinoma
- •Mesonephric carcinoma
- •Measurable disease, defined as ≥1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR as ≥ 10 mm by spiral CT scan
- •Must have ≥ 1 target lesion
- •Tumors within a previously irradiated field are designated as target lesions provided there is documented disease progression or biopsy confirmed persistent disease ≥ 90 days after completion of radiotherapy
- •Must have received 1 prior chemotherapeutic regimen for management of endometrial cancer
- •Initial treatment may have included non-cytotoxic agents or high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment
- •No more than one prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
- •One additional non-cytotoxic regimen for management of recurrent or persistent disease is allowed
- •Not eligible for a higher priority GOG protocol, if one exists (i.e., any active Phase III GOG protocol for the same patient population)
- •GOG performance status 0-2
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •AST and ALT ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- •No neuropathy (sensory and motor) > grade 1, according to NCI CTCAE v3.0
- •No active infection requiring antibiotics (except an uncomplicated urinary tract infection)
- •No other invasive malignancies within the past 5 years except non-melanoma skin cancer
- •No prior cancer treatment that contraindicates study therapy
- •Recovered from prior surgery, radiotherapy, or chemotherapy
- •At least 1 week since prior hormonal therapy for endometrial cancer
- •At least 3 weeks since prior biological therapy, immunotherapy, or other therapy for endometrial cancer
- •At least 4 weeks since prior radiotherapy
- •More than 3 years since prior radiotherapy for localized breast cancer, head and neck cancer, or skin cancer and
- •No recurrent or persistent breast cancer, head and neck cancer, or skin cancer
- •More than 3 years since prior adjuvant chemotherapy for localized breast cancer
- •No recurrent or metastatic breast cancer
- •No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of endometrial cancer
- •No prior chemotherapy for any abdominal or pelvic tumor except for the treatment of endometrial cancer
- •No prior gemcitabine hydrochloride
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Gemcitabine Hydrochloride (Drug)
结局指标
主要结局
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
时间窗: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
时间窗: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
次要结局
未报告次要终点