A Phase II Evaluation of ABI-007 in the Treatment of Persistent or Recurrent Squamous or Nonsquamous Cell Carcinoma of the Cervix
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 26
- 主要终点
- Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
研究概览
简要总结
This phase II trial is studying how well ABI-007 works in treating patients with persistent or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, 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
OBJECTIVES:
I. Estimate the antitumor activity of ABI-007 in patients with persistent or recurrent squamous or nonsquamous cell carcinoma of the cervix who have failed on higher-priority treatment protocols.
II. Determine the nature and degree of toxicity of ABI-007 in this cohort of patients.
III. To determine the expression of the SPARC (secreted protein, acidic and rich in cysteine) protein in the tumor tissue and plasma (exploratory study) of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Persistent or recurrent squamous or nonsquamous cell carcinoma of the cervix with documented disease progression
- •Histologic confirmation of the original primary tumor
- •Measurable disease, defined as at least one target lesion that can be accurately measured in at least one dimension ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, or ≥ 10 mm when measured by spiral CT scan
- •Tumors within a previously irradiated field will be designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy
- •Must have received 1 prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent squamous or nonsquamous cell carcinoma of the cervix
- •Chemotherapy administered as a radiosensitizer is not a systemic chemotherapy regimen
- •Not eligible for a higher priority GOG protocol
- •GOG performance status 0, 1, or 2
- •No active infection requiring antibiotics
- •Platelet count ≥ 100,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •SGOT and alkaline phosphatase ≤ 2.5 times ULN
- •No neuropathy (sensory and motor) > grade 1
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No evidence of any other invasive malignancies within the past 3-5 years, except localized breast cancer, head and neck cancer, cervical cancer, or nonmelanoma skin cancer
- •No pre-existing hearing loss/tinnitus > grade 1
- •No concurrent amifostine or other protective agents
- •Recovered from effects of prior surgery, radiotherapy, or chemotherapy
- •Hormonal therapy directed at malignant tumor must be discontinued at least 1 week prior to study entry
- •Continuation of hormone replacement therapy permitted
- •At least 3 weeks since prior biological therapy and immunotherapy
- •No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
- •May have received 1 additional noncytotoxic (biologic or cytostatic) regimen, including monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction
- •No prior radiotherapy to any portion of the abdominal cavity or pelvis
- •Radiotherapy for the treatment of cervical cancer within the past 5 years allowed
- •Radiotherapy for localized breast cancer, head and neck or skin allowed provided completion > 3 years prior to study entry and remains free of recurrent or metastatic disease
- •No prior chemotherapy for any abdominal or pelvic tumor
- •Chemotherapy for the treatment of cervical cancer within the past 5 years allowed
- •Prior adjuvant chemotherapy for localized breast cancer provided completion > 3 years prior to study entry and remains free of recurrent or metastatic disease
- •No prior therapy with ABI-007 or any other taxane
- •No prior anticancer treatment that would preclude study therapy
- •No concurrent ritonavir, saquinavir, indinavir, nelfinavir, or anticonvulsants
排除标准
- 未提供
研究组 & 干预措施
Treatment (paclitaxel albumin-stabilized nanoparticle)
Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Paclitaxel Albumin-Stabilized Nanoparticle Formulation (Drug)
Treatment (paclitaxel albumin-stabilized nanoparticle)
Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
时间窗: Up to 5 yearsAssessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
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 for the first 6 months; then every 3 months x 2; then every 6 months 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.
次要结局
未报告次要终点