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[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer (PAZPET-1)

This study has been completed.
Information provided by (Responsible Party):
Imperial College London Identifier:
First received: March 22, 2012
Last updated: March 9, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Ovarian Neoplasm
Drug: Pazopanib and paclitaxel
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment [ Time Frame: 1 week ]
    Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant

Secondary Outcome Measures:
  • The proportion of women who experience side effects from the combination of paclitaxel and pazopanib [ Time Frame: 12 months ]
    Core study assessments including physical examination, vital signs, ECG, and adverse event reporting

  • The proportion of patients responding to combination paclitaxel and pazopanib [ Time Frame: 12 months ]

Enrollment: 16
Study Start Date: July 2012
Study Completion Date: April 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pazopanib and paclitaxel Drug: Pazopanib and paclitaxel
Pazopanib 800mg od for 7 days, followed by 18 weeks of combination therapy (paclitaxel 80mg/m2 weekly and pazopanib 800mg od). Following the completion of combination therapy, patients will continue on maintenance pazopanib 800mg od until disease progression.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01608009

United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Southend University Hospital NHS Foundation Trust
Southend, United Kingdom
Sponsors and Collaborators
Imperial College London
Study Director: Rohini Sharma, MD Imperial College London
Principal Investigator: Timothy Crook, MD Southend University Hospital NHS Foundation Trust
  More Information

Responsible Party: Imperial College London Identifier: NCT01608009     History of Changes
Other Study ID Numbers: CRO1627
Study First Received: March 22, 2012
Last Updated: March 9, 2017

Keywords provided by Imperial College London:
platinum resistant
ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 24, 2017