A Phase II Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Tumor Response
研究概览
简要总结
This is a study for patients with advanced testicular cancer. This research study involves treatment with oxaliplatin, paclitaxel, and gemcitabine, which is an investigational chemotherapy combination. This study is for patients who have not responded to standard cisplatin-containing chemotherapy or the cancer has returned after such treatment.
This research is being done to assess the effectiveness of the proposed combination of medications for this type of cancer.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prior histologic or serologic confirmation of testicular or extragonadal germ cell neoplasm not amenable to surgical cure
- •Must have refractory germ cell neoplasm defined as one or more of the following:
- •patients who progress during or within 4 weeks of cisplatin-containing tx, OR - patients who have failed initial salvage chemotx regimens, including high-dose tx (chemotx with stem cell support), POMB-ACE tx, VeIP, or VIP
- •Must have one or more of the following (check all that apply):
- •unidimensionally measurable doze assessed within 14 days prior to registration,
- •elevated β-HCG > 20 mIU assessed within 24-48 hours prior to registration, OR
- •AFP > 2 x uln assessed within 5-7 days prior to registration
- •Note: Soft tissue dz, which has been radiated in the 2 months prior to registration, is not assessable as measurable dz.
- •X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of registration
- •May have received prior surgery or RT. At least 3 weeks must have elapsed since completion of previous tx and must have recovered from any adverse effects
- •Zubrod PS less than or equal to 2
- •Greater than or equal to 16 years of age
- •AGC greater than or equal to 1.5; platelets greater than or equal to 100,000
- •Total bilirubin < 2.5 x uln; SGOT and alk phos < 5 x uln (obtained within 14 days prior to registration)
- •LDH (obtained within 7 days prior to registration)
- •Creatinine < 2.5 x uln or calc or meas CrCl greater than or equal to 40 ml/min (obtained within 14 days prior to registration; patient must not be on renal dialysis)
- •Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to registration)
- •Men of reproductive potential must agree to use effective contraceptive method
- •Signed informed consent (including HIPAA authorization)
排除标准
- •Prior tx with cytotoxic or experimental agents within 14 days prior to registration
- •Evidence of concurrent infection (T > 96.8F but < 101.5F; WBC < 11.0 unless these values can be ascribed to another tumor-related phenomena)
- •Other prior malignancy, except adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which patient is currently in chemoradiation (CR), or any other cancer from which patient has been disease-free for 5 years
结局指标
主要结局
Tumor Response
时间窗: Every 6 weeks
Tumor Response
时间窗: From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 years
Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
次要结局
- Progression(Every 9 wks)
- Progression-Free Survival(Through study completion, about 9 years)
- Overall Survival(Through study completion, about 9 years)