NCT00072228撤回1 期
Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors
Daiichi Pharmaceuticals3 个研究点 分布在 1 个国家开始时间: 2003年11月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of soblidotin and gemcitabine in treating patients with locally advanced or metastatic solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with locally advanced or metastatic solid tumors.
- Determine the dose-limiting toxic effects of this regimen in these patients.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- •Minimally pretreated
- •Not refractory to prior gemcitabine therapy
- •No disease progression during initial treatment with gemcitabine
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present)
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular
- •Ejection fraction at least 40% by MUGA
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No psychiatric disorder that would preclude study consent or compliance
- •No concurrent severe or uncontrolled underlying medical disease unrelated to the tumor that would compromise patient safety or affect study outcome
- •No hypersensitivity to gemcitabine
- •No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off all therapy for that disease for at least 2 years
- •No serious infection
- •No grade 2 or greater neuropathy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent anticancer biologic therapy
- •Chemotherapy
- •See Disease Characteristics
- •Recovered from prior chemotherapy
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Recovered from prior radiotherapy
- •No concurrent anticancer radiotherapy
- •Concurrent localized palliative radiotherapy to a non-indicator lesion for pain control allowed only if other methods of pain control are ineffective
- •At least 4 weeks since prior major surgery and recovered
- •More than 28 days since prior investigational drugs, including analgesics or antiemetics
- •At least 4 weeks since prior myelosuppressive therapy
- •No other concurrent anticancer therapy
- •No other concurrent anticancer cytotoxic therapy
排除标准
- 未提供
研究者
研究点 (3)
Loading locations...
相似试验
已完成
2 期
S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or CholangiocarcinomaExtrahepatic Bile Duct CancerGallbladder CancerNCT00033540SWOG Cancer Research Network57
已完成
2 期
S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) CancerKidney CancerNCT00058318SWOG Cancer Research Network43
已完成
2 期
Gemcitabine, Cisplatin, and Gefitinib in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung CancerLung CancerNCT00103051European Organisation for Research and Treatment of Cancer - EORTC
撤回
2 期
Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or CarboplatinFallopian Tube CancerPeritoneal Cavity CancerOvarian CancerNCT00369954Gynecologic Oncology Group
已完成
2 期
Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland TumorHead and Neck CancerNCT00079079NCIC Clinical Trials Group34