Phase II Study of Erlotinib Plus Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response Rates
研究概览
简要总结
This phase II trial is studying the side effects of giving erlotinib together with carboplatin and paclitaxel and to see how well it works in treating patients with stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. To establish whether the addition of OSI-774 (Tarceva) to the combination of paclitaxel and carboplatin encourages pathologic complete response (pCR) rates in patients with Stage III optimally cytoreduced (stratum 1) and Stage III suboptimally cytoreduced or Stage IV (stratum 2) ovarian, primary peritoneal or fallopian tube carcinomas when used as front line therapy.
II. To determine the degree and type of toxicity associated with this combined regimen.
SECONDARY OBJECTIVES:
I. To establish baseline epidermal growth factor receptor (EGFR), truncated EGFR (EGFRvIII), phosphorylated EGFR (pEGFR) and related signal transduction pathway protein expression levels (such as the mitogen activated protein kinase p-ERK, AKT phosphorylation and Her2/neu) in tumor samples obtained pretreatment, and to correlate these with achieving pCR.
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
- •Patients with a histologic diagnosis of primary peritoneal carcinoma, fallopian tube epithelial ovarian carcinoma, Stage III with either greater than 1 cm (suboptimal) residual disease following initial surgery, or Stage IV; all patients must either have had appropriate surgery for ovarian, fallopian tube or peritoneal carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage or must be unresectable at time of diagnosis (to be determined by gynecological oncologist); cytology alone is not adequate
- •Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS)
- •Patients must begin chemotherapy on this study no more than twelve weeks postoperatively
- •Patients must not have received chemotherapy within five years prior to enrollment
- •ECOG performance status =< 2 (Karnofsky >= 60%)
- •Absolute neutrophil count >= 1,500/uL
- •Platelets >= 100,000/uL
- •Total bilirubin =< 1.5 x institutional upper limit of normal
- •AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal
- •Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- •Neuropathy (sensory and motor) =< CTC grade 1
- •No medical contraindications to planned regimen
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients who have had courses of chemotherapy within the five years prior to entering the study
- •Patients may not be receiving any other investigational agents
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition OSI-774 or other agents used in the study
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant women are excluded from this study because OSI-774 has the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with OSI-774; these potential risks may also apply to other agents used in this study
- •Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
研究组 & 干预措施
Paclitaxel, carboplatin, erlotinib
Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib
干预措施: paclitaxel (Drug)
Paclitaxel, carboplatin, erlotinib
Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib
干预措施: carboplatin (Drug)
Paclitaxel, carboplatin, erlotinib
Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib
干预措施: erlotinib (Drug)
结局指标
主要结局
Pathologic Complete Response Rates
时间窗: Up to 7 years
Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment.
The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
时间窗: For the duration of the study up to 7 years
Adverse event assessment
次要结局
- To Determine the Tolerability of Twelve Months of Maintenance Treatment(Twelve months of maintenance)
- To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin(The duration of the study)
- To Measure EGFR Gene Amplification in Tumor Specimens(The duration of the study for up to 7 years)