[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer
This trial is active, not recruiting.
|Treatment||pazopanib and paclitaxel|
|Sponsor||Imperial College London|
|Start date||July 2012|
|End date||May 2015|
|Trial size||17 participants|
|Trial identifier||NCT01608009, CRO1627|
The purpose of this study is to assess [18F] -fluciclatide as a biomarker of response to pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel in platinum-resistant ovarian cancer patients.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment
time frame: 1 week
The proportion of women who experience side effects from the combination of paclitaxel and pazopanib
time frame: 12 months
The proportion of patients responding to combination paclitaxel and pazopanib
time frame: 12 months
Female participants at least 18 years old.
Inclusion Criteria: - Age ≥ 18 years - Diagnosis of relapsed ovarian cancer - Responded to at least on one line of prior platinum based therapy - Relapsed within platinum resistant interval (≤6months) - Eastern Cooperative Oncology Group (ECOG) performance status of <2 - Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥25mm using conventional techniques - Satisfactory baseline haematologic and organ function: - Haematologic: Absolute neutrophil count > or = 1.5 X 10^9/L; Platelets > or = 100 X 10^9/L; Haemoglobin > or = 9g/dL; PT or INR < or = 1.2 x ULN; PTT < or = 1.2 x ULN - Hepatic: Bilirubin < or = 1.5 X ULN; AST or ALT < or = 2.5 X ULN - Renal: Serum creatinine < or = 1.5 mg/dL; Or if >1.5 mg/dL, calculated creatinine clearance > or = 50mL/min; UPC <1 Exclusion Criteria: - Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study. - Treatment with any of the following anti-cancer therapies: - radiation therapy 28 days prior to the first dose of pazopanib OR - surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR - chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib - Treatment with anti-angiogenic therapy - Presence of gross ascites - Clinically significant peripheral neuropathy - Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study
|Official title||Phase 1b Exploratory Study of [18F]Fluciclatide-PET as a Marker of Angiogenic Response to Combination Therapy With the Pan-VEGF Inhibitor, Pazopanib, and Weekly Paclitaxel in Platinum Resistant Ovarian Cancer|
|Principal investigator||Timothy Crook, MD|
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