EUCTR2007-007615-82-GB进行中（未招募）1 期
A Phase I/II single-arm trial to evaluate the combination of cisplatin and gemcitabine with the mTOR inhibitor temsirolimus for treatment of advanced cancers, including first-line treatment of patients with advanced transitional cell carcinoma of the urothelium. - TOTEM: Trial of Temsirolimus for Advanced Cancers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Provision of written, informed consent, signed and dated, prior to any trial-specific procedures, sampling or analyses.
- •2.Age =16 years.
- •3.Histologically-confirmed locally advanced/metastatic non-haematological malignancy (a diagnosis based upon cytology is not acceptable).
- •Locally advanced and/or metastatic disease which is not amenable to curative treatment with surgery or radiotherapy.
- •i.Any locally-advanced and/or metastatic solid cancer for which gemcitabine and cisplatin is either an accepted standard treatment or for which there is no remaining standard treatment, but gemcitabine and cisplatin with temsirolimus is a reasonable option in the context of a clinical trial. Any number of previous lines of therapy are permitted.
- •ii.Locally advanced and/or metastatic transitional cell carcinoma of the bladder (or other urinary tract sites), as in Phase II, may be included in the dose escalation cohort.
- •i.Radiologically measurable (RECIST 1.1), locally advanced and/or metastatic (T4b Nany Many, Tany N2-3 Many or Tany Nany M1) transitional cell carcinoma (pure or mixed histology) of (upper or lower) urinary tract, including bladder cancer, which is not amenable to curative treatment with surgery or radiotherapy.
- •ii.No prior systemic therapy for locally advanced or metastatic disease; patients who have received prior neoadjuvant or adjuvant chemotherapy for potentially-curable urothelial cancer (up to 4 cycles), completed at least 6 months prior to first documented disease progression, will be eligible.
- •4.Estimated life expectancy = 3 months.
- •5.WHO Performance Status 0-2.
- •6.Fit to receive cisplatin-containing combination chemotherapy.
- •7.No prior radiotherapy within 1 month prior to registration or involving more than 30% of total bone marrow volume.
- •8.No investigational drug within 1 month prior to registration.
- •9.Adequate renal function (GFR >60ml/min, uncorrected for surface area and measured by isotopic means).
- •10.Adequate bone marrow function (absolute neutrophil count =1.5 x 109/L and platelets =100 x 109/L at screening).
- •11.Adequate liver function (Bilirubin =1.5 x ULN, and ALT and ALP =2.5 x ULN, at screening or >5x ULN if judged by the investigator to be related to liver metastases.
- •12.Prothrombin time (PT) or International normalized ratio (INR) =1.5.
- •13.Written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Patients with transitional cell carcinoma in whom subsequent radical treatment is being considered with a view to possible cure.
- •2.Previous malignancy in the past 3 years other than non-melanoma skin cancer, cervical carcinoma in situ, incidental localised prostate cancer or previous non-invasive TCC.
- •3.Previously-identified central nervous system (CNS) metastases - routine screening by cross-sectional imaging of the head is not a requirement for trial entry and should only be performed if clinically indicated.
- •4.Women who are pregnant or breast feeding.
- •5.Men and women not prepared to practice a medically acceptable* form of birth control during the trial and for 6 months after the end of treatment.
- •i.Women of child bearing potential* must have a negative pregnancy test performed within 7 days prior to the start of treatment and be prepared to use a medically acceptable method of contraception** during and for 6 months after the end of treatment if they are at present or become sexually active during the trial.
- •ii.Women not of child bearing potential*** must insist that their partners use a condom during the trial and for 6 months after the end of treatment if they are at present or become sexually active during the trial.
- •*Women of child bearing potential are defined as any female who has experienced menarche and who does not meet the criteria for women not of childbearing potential.
- •**Medically acceptable methods of contraception include:
- •Oral contraception and male condom
- •Intra-uterine device (IUD) and male condom
- •Diaphragm with spermicide and male condom
- •Injected or implanted hormonal methods of contraception and male condom
- •Vasectomy and male condom
- •Complete sexual abstinence
- •*** Women not of child bearing potential are defined as women who are postmenopausal or permanently sterilised (e.g. tubal occlusion, hysterectomy or bilateral salpingectomy).
- •6.Known infection with human immunodeficiency virus (HIV) or chronic hepatitis B or C infection or any other clinically significant bacterial or fungal infection. Note: testing not required unless clinically indicated.
- •7.Symptomatic coronary artery disease, myocardial infarction within the last 6 months, congestive cardiac failure (New York Health Association (NYHA) class III or IV), uncontrolled or symptomatic cardiac arrhythmia.
- •8.Concurrent anticoagulant therapy with warfarin or un-fractionated heparin - patients requiring anti-coagulation may be entered after successful conversion to low molecular weight heparin (LMWH).
- •9.Concomitant medications which have known adverse interactions with the trial treatment.
研究者
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