Study of a marker of angiogenic response to combination therapy with pazopanib, and weekly paclitaxel in platinum resistant ovarian cancer | Not Recruiting
Study of a marker of angiogenic response to combination therapy with pazopanib, and weekly paclitaxel in platinum resistant ovarian cancer
PAZ-PET
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Gynaecological cancer, ovarian cancer
Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN38286161
Primary Trial ID Number
Summary
http://cancerhelp.cancerresearchuk.org/trials/a-study-see-how-well-pet-scans-pick-up-blood-supply-changes-ovarian-cancer-treated-pazopanib-paclitaxel-pazpet-1
Research Details
  • 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.
Phase
Phase I/II
Study Design
Non-randomised, interventional study
Study Type
Interventional
Intervention

fluciclatide-PET, PET imaging technique with novel tracer

Intervention Type
Drug
Primary Outcome Measures
  • Response to therapy
Secondary Outcome Measures
  • No secondary outcome measures
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
Gender
Female
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 17; UK Sample Size: 17
Participant 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
Participant 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
Trial Location(s)
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London
England
W12 0HS
Trial Contact(s)
Primary Trial Contact
Dr Rohini Sharma
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
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
EudraCT Number
Sorry, this information is not available
Funder(s)
  • GSK (UK)
  • Higher Education Funding Council for England
  • Medical Research Council
Other Study ID Numbers
9301
Sponsor(s)
Imperial College London (UK)
Key Dates

Recruitment Start Date

01 Nov 2011

Recruitment End Date

01 Nov 2012

Trial Start Date

01 Nov 2011

Trial End Date

01 Nov 2012

Date Assigned

10 Aug 2011

Last Updated

26 Jul 2012