fallopian tube ovarian cancer
Conditions
Interventions
Phase Ib part: Doses of carboplatin, paclitaxel and pazopanib will be
escalated. (for details refer to Chapter 4 of this study protocol.)
Patients in the Phase I part will continue pazopanib (at the
Sponsors
European Organisation for Research in Treatment of Cancer (EORTC)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for both phase Ib and II: - Female subjects more than 18 years of age - Histologically confirmed diagnosis of ovarian, fallopian tube, or peritoneal carcinoma with recurrent disease. - All patients with at least one earlier platinum treatment can be included but should be platinum refractory (progression during platinum therapy) or resistant(progression within 6 months after last platinum dose). There is no restriction on the number of prior lines. Non-platinum treatment after proven platinum-resistance/refractory disease is allowed. - Evaluable (measurable or non-measurable) disease by RECIST version 1.1 - Patient must be able to receive the infusions (paclitaxel, carboplatin) and swallow the tablets (pazopanib) - WHO Performance status must be
Exclusion criteria
Exclusion criteria: Exclusion criteria for both phase Ib and II: - known metastatic disease to the brain or leptomeninges -other prior malignancies treated primarily or for recurrence within 2 years prior to inclusion in this study, except for completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma of the skin or cervix of the uterus. - treatment with any of the following anti-cancer therapies: - Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of study drug. - Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days (28 days for drugs with a longer half-life) of a drug prior to the first dose of study drug. - ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia and >Grade 2 peripheral neuropathy. - known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs similar or related to paclitaxel, carboplatin and pazopanib - unstable or serious condition e.g. uncontrolled infection requiring systemic therapy - prior major surgery or trauma within 28 days prior to the first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement and diagnostic endoscopic procedures not considered to be major) -history of any of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the NYHA - inadequately controlled hypertension (systolic blood pressure (SBP) >=140 mmHg, or diastolic blood pressure (DBP) >= 90 mmHg). Initiation or adjustment of blood pressure medication is permitted prior to the study entry. - prolonged corrected QT interval (QTc) defined as >480 msecs using Bazett*s formula - history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. - evidence of active bleeding or bleeding diathesis - clinically significant gastro-intestinal tract abnormalities that may increase the risk for GI bleeding including but not limited to: active peptic ulcer disease, known intraluminal metastatic lesion/s with risk of bleeding, inflammatory bowel disease (e.g. ulcerative colitis, Crohn*s disease), history of bowel obstruction (excluding postoperative (i.e. within 4 weeks post surgery)), or other GI condition with increased risk of perforation -clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: malabsorption syndrome, major resection of stomach or small bowel. -Patient with possible gastrointestinal tumor related invasion are not eligible to participate in the study - known endobronchial lesions and/or lesions infiltrating major pulmonary vessels - hemoptysis in excess of 2.5mL (one half tea spoon) within 8 weeks prior to first dose of study drug. - any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;Exclusion criteria f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase Ib part: Primary end point: * To document the dose limiting toxicity (DLT) within the first 6 weeks (at the end of week 3 and week 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase Ib Secondary end points: * PK data of paclitaxel, carboplatin and pazopanib * Safety and tolerability of the combination, according to CTCAE 4.0 * Response Rate * Predictive biomarkers | — |
Countries
Netherlands
Outcome results
None listed