Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01608009
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : March 10, 2017
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasm Drug: Pazopanib and paclitaxel Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : July 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : April 2016

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01608009

Layout table for location information
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
Layout table for investigator information
Study Director: Rohini Sharma, MD Imperial College London
Principal Investigator: Timothy Crook, MD Southend University Hospital NHS Foundation Trust

Layout table for additonal information
Responsible Party: Imperial College London Identifier: NCT01608009     History of Changes
Other Study ID Numbers: CRO1627
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Keywords provided by Imperial College London:
platinum resistant
ovarian cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action