NCT03093155已完成2 期
A Randomized Phase II Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab in Recurrent or Persistent Platinum-resistant/Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab
研究概览
简要总结
This is a randomized, two-arm, open-label Phase II multicenter study designed to examine the effects of adding bevacizumab to ixabepilone for the treatment of patients who have recurrent or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. Its primary objective is to assess whether adding bevacizumab to ixabepilone improves progression-free survival in its target population. Study participants will be stratified by (a) study site and (b) previous receipt of bevacizumab prior to randomization.
详细描述
The primary objective of this study is as follows:
- To assess the activity of ixabepilone with bevacizumab compared to ixabepilone alone in patients with recurrent or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. We will assess this by comparing the ixabepilone +bevacizumab (experimental) arm to the ixabepilone-alone (control) arm for an improvement in median progression free survival (PFS).
The secondary objectives of this study are as follows:
- To compare the experimental arm to the control arm for increases in objective response rate (ORR) and durable disease control rate (DDCR).
- To compare the experimental arm to the control arm for an increase in overall survival (OS).
- To assess the safety profile of ixabepilone in combination with bevacizumab in ovarian, fallopian tube, or primary peritoneal cancer patients.
- To assess whether prior treatment with bevacizumab impacts future response to bevacizumab in combination with ixabepilone.
In addition to the primary and secondary objectives of this study, there are additional exploratory/correlative objectives. The exploratory/correlative objectives of this study are as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have platinum-resistant/refractory (i.e., platinum-free interval <6 months) recurrent or persistent histologically confirmed epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer.
- •Patients may have serous, endometrioid, clear cell, carcinosarcoma, or transitional cell/malignant Brenner, mixed, or undifferentiated histologies.
- •Patients must have specimen available for immunohistochemistry for class III β-tubulin status; recurrent tumor specimen is preferred, though this may be performed on primary tumor if no recurrent tumor is available.
- •All patients must have measurable disease. Measurable disease is defined as lesions that can be measured by physical examination or by means of medical imaging techniques. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation or plain x-ray, or ≥ 10 mm when measured by spiral CT and/or MRI. Ascites and pleural effusions are not to be considered measurable disease.
- •Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST v1.1 Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- •At the time of initial surgery, patients may have been optimally (<1 cm diameter residual disease) or sub-optimally (≥1 cm diameter of residual disease) debulked.
- •Patients with measurable recurrent disease of any previous stage (I-IV) are eligible to enrollment.
- •The diagnosis must be histologically confirmed by a gynecologic pathologist.
- •Patients must have adequate bone marrow, kidney, and liver function:
- •Absolute neutrophil count greater than or equal to 1500 cells/mm3
- •Platelets greater than or equal to 100,000/uL
- •Renal function: creatinine less than or equal to 2.0 mg/dL
- •Hepatic function: Bilirubin ≤ 1.5 X laboratory normal
- •SGOT/SGPT ≤ 3 X laboratory normal.
- •Patients must have an ECOG performance status of 0-
- •Patients must have signed an approved informed consent.
- •Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy. They should be free of significant infection.
- •Patients must have received prior treatment with taxanes. There is no limit on the number of prior lines of therapy.
- •Patients may have received prior bevacizumab therapy alone or in combination with chemotherapy. A 3-week washout period is required.
- •Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception (section 7.5.3).
- •Patients must be at least 18 years of age.
排除标准
- •Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers, are excluded if there is any evidence of other malignancy present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
- •Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias within 6 months of registration (NYHA classification III-IV).
- •Patients with any unstable medical issue (including cardiac issues as above, active treatment for symptomatic pulmonary embolism, CVA, renal or hepatic insufficiency, active infection/sepsis requiring intravenous antibiotics). In patients who have undergone surgery, 28 days should elapse before initiation and the surgical site should be adequately healed.
- •Known brain/leptomeningeal involvement of the disease, active neurological disease such as uncontrolled seizure disorder or moderate to severe dementia.
- •Patients who have received prior therapy with any covalent irreversible anti-angiogenic tyrosine kinase inhibitor (e.g., vandetanib).
- •Patients known to be seropositive for human immunodeficiency virus (HIV) and active hepatitis, even if liver function studies are in the eligible range.
- •Known hemorrhagic diathesis or active bleeding disorder, including platelet count <100,000/uL, or inadequate granulocytes, including an absolute neutrophil count <1500 cells/mm.
- •Any hypersensitivity to Cremophor® EL or polyoxyethylated castor oil.
- •CTCAE grade 2 or higher peripheral neuropathy.
研究组 & 干预措施
Ixabepilone
Active Comparator
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
干预措施: Ixabepilone (Drug)
Ixabepilone + Bevacizumab
Experimental
Ixabepilone 20 mg/m2 days 1, 8, 15
- Bevacizumab 10 mg/kg days 1, 15 Q 28 days
干预措施: Ixabepilone (Drug)
Ixabepilone + Bevacizumab
Experimental
Ixabepilone 20 mg/m2 days 1, 8, 15
- Bevacizumab 10 mg/kg days 1, 15 Q 28 days
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab
时间窗: Up to 37 months
Progression-free survival (PFS), the primary endpoint, will be defined as the length of time from randomization to disease recurrence, disease progression, or death for any reason. The timeframe was updated upon results entry.
次要结局
- Objective Response Rate (ORR)(Up to 37 months)
- Overall Survival (OS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab(Up to 37 months)
- Number of Participants With Treatment Related SAEs(Up to 37 months)
- Differences in Response to the Combination of Ixabepilone and Bevacizumab in Relationship to Previous Treatment With Bevacizumab and Taxanes(Up to 41 months)
- Durable Disease Control Rate (DDCR) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab(5 Years)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination DeficiencyTriple Negative Breast NeoplasmsHRpos Breast NeoplasmsBRCA 1 /2 and / or HRDBreast CancerNCT02789332German Breast Group107
已完成
2 期
Lapatinib in Combination With VinorelbineCancerNCT01013740Novartis Pharmaceuticals112
已完成
2 期
Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal CancerMetastatic Colorectal CancerNCT01991873AIO-Studien-gGmbH387
已完成
2 期
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)Early Breast CancerNCT04436744Hoffmann-La Roche221
Unknown
2 期
A Trial With Metronomic Low-dose Treosulfan, Pioglitazone and Clarithromycin Versus Standard Treatment in NSCLCSquamous Cell Lung CancerNon-Squamous Cell Lung CancerNon-Small Cell Lung CancerNCT02852083University Hospital Regensburg86