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 number NCT01608009
Secondary identifying numbers 9301, CRO1627
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

Study designNon-randomised, interventional study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific titlePhase 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 acronymPAZPET-1
Study objectivesPazopanib 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) studiedGynaecological cancer, ovarian cancer
Interventionfluciclatide-PET, PET imaging technique with novel tracer
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase I/II
Drug / device / biological / vaccine name(s)Paclitaxel, pazopanib
Primary outcome measureResponse to therapy
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/11/2011
Completion date01/11/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsPlanned Sample Size: 17; UK Sample Size: 17
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/2011
Date of final enrolment01/11/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Cyclotron Unit
London
W12 0HS
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
England
United Kingdom

Website http://www3.imperial.ac.uk/
ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Industry

GSK (UK)

No information available

Higher Education Funding Council for England
Private sector organisation / Other non-profit organizations
Alternative name(s)
HEFCE
Location
United Kingdom
Medical Research Council
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.