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

Health Conditions
  • Gynaecological cancer, ovarian cancer
Not Recruiting
Recruitment Status
ISRCTN38286161
Primary Trial ID Number
Summary
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.
Primary Outcome Measures
  • Response to therapy
Secondary Outcome Measures
  • No secondary outcome measures
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
ref: 10/S0801/36
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Female
Participant Age Range
Adult
Participant Type
Patient
Trial 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
Interventions
fluciclatide-PET, PET imaging technique with novel tracer
Design Details
Sorry, this information is not available
Study Design
Non-randomised, interventional study
Results Reporting
Sorry, this information is not available
Acronym
PAZ-PET
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
Secondary Trial Identifying Number
9301
Website
Sorry, this information is not available
Study Funded By
GSK (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
Imperial College London (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Nov 2011

Recruitment End Date

01 Nov 2012

Trial End Date

01 Nov 2012

Date added to Registry

10 Aug 2011

Last Updated

26 Jul 2012