Phase II Study of Genasense-Carboplatin-Paclitaxel-Combination in Uveal Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)
研究概览
简要总结
The goal of this clinical research is to learn if the combination of Genasense (oblimersen), carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety of this combination will also be studied.
详细描述
Study Drugs:
Oblimersen is designed to stop the body from making a protein that makes melanoma cells resistant to chemotherapy drugs. This may make carboplatin and/or paclitaxel more effective.
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
Study Drug Administration:
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a history of uveal melanoma and documented metastatic disease
- •Patients must have at least one measurable lesion as per revised RECIST Criteria. A measurable lesion is defined as a non-nodal lesions that is >/= 10 mm provided the CT slice is </=5 mm in thickness or a pathologic lymph node that is >/= 15 mm on the short axis provided the CT slice is </= 5 mm in thickness or Superficial skin lesion that is >/= 10 mm in diameter as assessed using calipers. Bone lesions are not considered measurable.
- •Patients may be previously untreated or may have received prior systemic therapy but no more than one systemic cytotoxic chemotherapy regimen and one targeted therapy for metastatic disease.
- •At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during therapy. If progression occurred during therapy, patient must have recovered from any side effects before starting GCP therapy.
- •At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow.
- •Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
- •Patients must have ECOG performance status of 0 -
- •Patients should be 18 years of age or older.
- •Patients must have adequate liver and renal function as defined by total bilirubin </=1.5 mg/dl, serum Lactate Dehydrogenase level no higher than 2.0 x UNL of the institution, transaminase (i.e., ALT and AST) levels no higher than 5 x UNL and serum creatinine </=1.5 mg/dl or estimated Creatinine Clearance >/=60 ml/min
- •Patients must have adequate bone marrow function as defined by an absolute neutrophil count of greater or equal to 1,500/mm3, and platelet count of greater or equal to 100,000/mm
- •Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.
- •Females of childbearing potential (non childbearing is defined as greater than one year post-menopausal or surgically sterilized) must use acceptable contraceptive methods (abstinence, intrauterine device, oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study.
排除标准
- •Patients who have received prior therapy with Genasense, any taxane or any of cisplatin analogues for systemic disease.
- •Patients whose site of primary melanoma is not in the choroid.
- •Patients who have a current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the prostate or cervix or other cancers treated for cure and with a disease-free survival longer than 2 years.
- •Patients with brain metastasis or history of brain metastasis (es).
- •Patients who are pregnant or breastfeeding.
- •Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
- •Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
- •Patients with unstable or serious concurrent medical conditions are excluded. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. PI or his designee shall make the final determination regarding appropriateness of enrollment.
- •Patients with a known hypersensitivity to cremophor containing anti-cancer agents.
- •Patients with one or more of the following as the only manifestations of disease are ineligible: Osteoblastic bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, carcinomatous lymphangitis, CNS metastases, lesions in a previously irradiated area that have not shown definite progression, or disease only inferred from laboratory tests or markers.
- •Patients with Gilbert's Syndrome.
- •Patients must not have had major surgery within the past 14 days.
- •Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
- •Known HIV disease or infection.
研究组 & 干预措施
Genasense + Paclitaxel + Carboplatin
Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
干预措施: Genasense (Drug)
Genasense + Paclitaxel + Carboplatin
Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
干预措施: Paclitaxel (Drug)
Genasense + Paclitaxel + Carboplatin
Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)
时间窗: Following two 3-week cycles
Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): \>30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): \>20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s
Number of Participants With Response
时间窗: Following two 3-week cycles
Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): \>30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): \>20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s
次要结局
未报告次要终点