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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01608009
First received: March 22, 2012
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Ovarian Neoplasm
Drug: Pazopanib and paclitaxel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant


Secondary Outcome Measures:
  • The proportion of women who experience side effects from the combination of paclitaxel and pazopanib [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Core study assessments including physical examination, vital signs, ECG, and adverse event reporting

  • The proportion of patients responding to combination paclitaxel and pazopanib [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 17
Study Start Date: July 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608009

Contacts
Contact: Rohini Sharma, MD r.sharma@imperial.ac.uk

Locations
United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Rohini Sharma, MD         
Principal Investigator: Rohini Sharma, MD         
Southend University Hospital NHS Foundation Trust Not yet recruiting
Southend, United Kingdom
Contact: Timothy Crook, MD         
Principal Investigator: Timothy Crook, MD         
Sponsors and Collaborators
Imperial College London
GlaxoSmithKline
Investigators
Study Director: Rohini Sharma, MD Imperial College London
Principal Investigator: Timothy Crook, MD Southend University Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01608009     History of Changes
Other Study ID Numbers: CRO1627
Study First Received: March 22, 2012
Last Updated: July 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
platinum resistant
ovarian cancer

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014