CTRI/2009/091/000057Other2 期
A Multicenter, Open-Label, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Combretastatin A-4 Phosphate in Combination With Paclitaxel and Carboplatin in Comparison With Paclitaxel and Carboplatin Against Anaplastic Thyroid Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- Oxigene Inc
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria:
- •I1.Subjects must have anaplastic thyroid carcinoma histologically or cytologically confirmed by a pathology review.
- •oA mixture of ATC with another type of thyroid malignancy is admissible.
- •oReview will be performed by a preselected local pathologist with expertise in endocrine malignancies.
- •I2.Subjects may have received prior chemotherapy as a component of combined modality therapy at time of diagnosis, but not subsequently for metastatic disease.
- •oSubjects are eligible if they have progressed or relapsed during or following initial combined modality therapy for regionally advanced disease.
- •oSubjects are eligible if they had metastatic disease at the time of commencement or during initial combined modality therapy. In this case, systemic therapy is limited to one chemotherapy regimen that is clearly administered contiguously, (i.e., in an uninterrupted primary therapeutic approach).
- •oSubjects who receive chemotherapy for metastatic disease after completing prior combined modality approach are ineligible.
- •oSubjects may have received prior chemotherapy as a component of combined modality therapy at time of diagnosis, but not subsequently.
- •I3.A minimum of 3 weeks must have elapsed from completion of radiation therapy until first dose of study drug.
- •I4.A minimum of 3 weeks must have elapsed from the time a subject last received chemotherapy until the first dose of study drug (6 weeks for therapy known to be associated with delayed toxicity such as nitrosureas or mitomycin-C).
- •I5.Subjects must have no clinically important sequelae from any prior surgery or radiotherapy.
- •I6.Subjects with bulky thyroid/neck masses and/or suspicion of airway obstruction must undergo screening (indirect or direct laryngoscopy) to ensure patency of the trachea/airway prior to study enrollment and treatment.
- •oSubjects with a tracheostomy are eligible.
- •I7.Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Score  2.
- •I8.Life expectancy ≥ 12 weeks.
- •I9.Subjects must have adequate bone marrow reserve as evidenced by:
- •oAbsolute neutrophil count (ANC) > 1,500/L (without growth factors).
- •oPlatelet count > 100,000/L
- •I10.Subjects must have adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL ( 177 mol/L).
- •I11.Subjects must have adequate hepatic function as evidenced by:
- •oSerum total bilirubin 2X greater than the upper limit of normal (ULN) (3X ULN in subjects with liver metastases).
- •oAST (aspartate aminotransferase)/ALT (alanine aminotransferase) 3X the ULN for the local reference lab (5X the ULN for subjects with liver metastases).
- •I12.Subjects must be at least 18 years old.
- •I13.Subjects or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
- •I14.All women of childbearing potential must have a negative serum pregnancy test. (Women who are ≥2 years post-menopausal, post-hysterectomy or have had a surgical sterilization do not require pregnancy test.)
- •I15.Women of childbearing potential as well as fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication. (An effective form of contraception is an oral contraceptive or a double barrier method.)
排除标准
- •E1.Subjects with tumors confined to the thyroid.
- •E2.Subjects with a uncontrolled, clinically significant active infection
- •E3.Clinically active brain metastasis, including symptomatic involvement, evidence of cerebral edema by prior CT or MRI, radiographic evidence of progression of brain metastasis since definitive therapy, or continued requirement for corticosteroids for cerebral edema.
- •E4.Subjects who receive chemotherapy for metastatic ATC after completion of a combined modality approach.
- •E5.Subjects with history of malignancies other than ATC except: 1) preceeding lower grade thyroid malignancy; 2) curatively treated basal cell carcinoma of the skin; 3) curatively treated cervical intra-epithelial neoplasia; 4) curatively treated localized prostate cancer with a current PSA of < 4.0 mg/dL or μg/L. (Subjects with other curatively treated malignancies who have no evidence of metastatic disease will be considered after discussion with the Medical Monitor.)
- •E6.Subjects with known intolerance of or hypersensitivity to CA4P or required premedications, or known uncontrolled hypersensitivity to paclitaxel, or carboplatin or CT contrast dye, or any of their components.
- •E7.Subjects who are receiving concurrent investigational therapy or who have received investigational therapy for any indication within 28 days of the first scheduled day of dosing. (Investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication.)
- •E8.Subjects with ≥Grade 3 peripheral neuropathy.
- •E9.Subjects who are pregnant or lactating.
- •E10.Subjects with a history of prior cerebrovascular event, including transient ischemic attack.
- •E11.Subjects with uncontrolled hypertension defined as blood pressure > 150/100 mm Hg despite medication.
- •E12.Subjects with symptomatic vascular disease (e.g., intermittent claudication).
- •E13.Subjects with a history of unstable angina pectoris pattern, myocardial infarction (including non-Q wave MI) within the past 6 months, or NYHA Class III and IV congestive heart failure.
- •E14.Subjects with a history of torsade de pointes, ventricular tachycardia, ventricular fibrillation or congenital long QT syndrome.
- •E15.Subjects with bradycardia (<60 b/m) or heart block (excluding 1st degree block, consisting of PR interval prolongation only).
- •E16.Subjects with ECG findings of clinically significant ventricular arrhythmia, new ST segment elevation or depression, or new Q wave on ECG. (PVCs are not excluded)
- •E17.Subjects with QTc > 450 ms for males and >470 ms for females.
- •E18.Subjects requiring on-going treatment with any drugs known to prolong the QTc interval, including anti-arrhythmic medications (see APPENDIX 5 for list of medications).
- •E19.Subjects with ejection fractions less than normal (i.e. <45%) on echocardiogram.
- •E20.Subjects with potassium concentrations below 4.0 mEq/L (or mmol/L), magnesium concentrations below 1.8 mmol/L
- •oSupplements may be used to increase electrolyte levels
- •E21.Subjects with a history of solid organ transplant or bone marrow transplant.
- •E22.Subjects with any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject?s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
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