Clinical trial NCT01608009: [18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Neoplasm
Keywords: platinum resistant
ovarian cancer
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2012-05-30
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment
timeFrame: 1 week
Secondary outcomes:
measure: The proportion of women who experience side effects from the combination of paclitaxel and pazopanib
timeFrame: 12 months
measure: The proportion of patients responding to combination paclitaxel and pazopanib
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Southend
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
Study officials:
affiliation: Imperial College London
name: Rohini Sharma, MD
role: STUDY_DIRECTOR
affiliation: Southend University Hospital NHS Foundation Trust
name: Timothy Crook, MD
role: PRINCIPAL_INVESTIGATOR
References: