Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Cancer Institute, Naples
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Cytologic / histologic diagnosis of stage IC-IV ovarian cancer
Disease progressed during first line chemotherapy or disease relapsed within 6 months after the last platinum treatment
Disease evaluable by RECIST or Ca 125 GCIG criteria
No residual peripheral neurotoxicity from previous chemotherapy treatment
PS 0-1
Aged at least 18 and not greater than 75 years.
Life expectancy of at least 3 months
Able to swallow and retain oral medication
Written informed consent prior to performance of study specific procedures or assessments
Ability and willingness to comply with treatment and follow up assessments and procedures
You may not be if
· • Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
Previous treatment with weekly paclitaxel
More than 2 previous chemotherapy treatments
Serious heart disease, including heart failure, atrioventricular block of any degree, serious arrhythmia or history of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
Impairment of renal function (patients should have 2 functioning kidneys): creatinine 1.5 times the upper normal limit - UNL; calculated creatinine clearance \< 50 mL/min; urine protein to creatinine ratio \> or = 1: then, a 24-hour urine protein must be assessed and subject must have a 24-hour urine protein value \<1gr to be eligible
Impairment of liver function (SGOT or SGPT \> or = 2.5 UNL, alkaline phosphatase \> 2.5 ULN, total bilirubin \> 1.5 times the UNL)
Prothrombin time (PT) or international normalized ratio (INR) or activated partial thromboplastin time (PTT) \> 1.2 times the UNL
Pregnancy, breast feeding, or inadequate contraception
Unable to discontinue prohibited medications (see protocol section 6.7)
Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including but not limited to malabsorption syndrome, major resection of the stomach or small bowel that could affect drug absorption, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment, signs or symptoms of GI obstruction
Any unstable or serious concurrent condition
Prolongation of corrected QT interval (QTc) \>480 ms
History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
Macroscopic hematuria
Major surgery or trauma within 30 days
Hypertension uncontrolled with adequate therapy (systolic blood pressure (BP) of \> or = 140mmHg, or diastolic BP of \> or = 90mmHg)
Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity
Present or suspected haemorrhagic syndromes
Patients' inability to access the centre due to area of residence
Clareo Health | Weekly Paclitaxel With or Without Pazopanib in Platinum Resistant or Refractory Ovarian Cancer
