Study of a marker of angiogenic response to combination therapy with pazopanib, and weekly paclitaxel in platinum resistant ovarian cancer

ISRCTN	ISRCTN38286161
DOI	https://doi.org/10.1186/ISRCTN38286161
ClinicalTrials.gov (NCT)	NCT01608009
Protocol serial number	9301, CRO1627
Sponsor	Imperial College London (UK)
Funders	GSK (UK), Higher Education Funding Council for England, Medical Research Council

Submission date: 10/08/2011
Registration date: 10/08/2011
Last edited: 20/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-see-how-well-pet-scans-pick-up-blood-supply-changes-ovarian-cancer-treated-pazopanib-paclitaxel-pazpet-1

Contact information

Dr Rohini Sharma
Scientific

MRC Cyclotron Unit
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Study information

Primary study design	Interventional
Study design	Non-randomised, interventional study
Secondary study design	Non randomised controlled trial
Scientific title	Phase 1b exploratory study of [18F]AH111585-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 acronym	PAZPET-1
Study objectives	Pazopanib is an unlicensed drug in tablet form that mainly targets the blood vessels supplying tumours and works best alongside other chemotherapy drugs. It attacks the protein on the blood vessels that is thought to be responsible for the resistance to chemotherapy. Paclitaxel is a licensed type of chemotherapy that is used to treat cancers and has been shown not only to shrink cancers but also target the abnormal blood vessels that supply nutrients to the cancer. The study uses PET (Positron Emission Tomography) scanner along with a very small amount of radioactive substance called "Tracer". As the blood vessels that supply nutrients to the tumour are destroyed there will be less of the tracer seen around the tumour. The PET scanner can detect that and gives us an idea about what is happening to the blood vessels that supply nutrients to the tumour. We collect blood and biopsy samples from patients and they will later be tested to gain more of an understanding about the way that the chemotherapy works and how good the scans are at detecting the chemotherapy changes.
Ethics approval(s)	ref: 10/S0801/36
Health condition(s) or problem(s) studied	Gynaecological cancer, ovarian cancer
Intervention	fluciclatide-PET, PET imaging technique with novel tracer
Intervention type	Drug
Phase	Phase I/II
Drug / device / biological / vaccine name(s)	Paclitaxel, pazopanib
Primary outcome measure(s)	Response to therapy
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/11/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	17
Key inclusion criteria	1. Age over 18 years 2. Diagnosis of relapsed ovarian cancer 3. Responded to at least on one line of prior platinum based therapy 4. Relapsed within platinum resistant interval (=6months) 5. Eastern Cooperative Oncology Group (ECOG) performance status of <2 6. Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter = 25mm using conventional techniques 7. Adequate organ system function 8. Female participants only
Key exclusion criteria	1. 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. 2. Treatment with any of the following anti-cancer therapies: 2.1. Radiation therapy 28 days prior to the first dose of pazopanib OR 2.2. Surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR 2.3. 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 3. Treatment with anti-angiogenic therapy 4. Presence of gross ascites 5. Clinically significant peripheral neuropathy 6. Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study
Date of first enrolment	01/11/2011
Date of final enrolment	01/11/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

MRC Cyclotron Unit

London
W12 0HS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

20/03/2019: No publications found, verifying study status with principal investigator.
06/03/2018: No publications found, verifying study status with principal investigator.
25/02/2016: No publications found, verifying study status with principal investigator.