Trial | NCT01608009  Report issue

Title

[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
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.
Study Started
Jul 31
2012
Primary Completion
May 31
2015
Study Completion
Apr 30
2016
Last Update
Mar 10
2017

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.

Pazopanib and paclitaxel Experimental

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
No Results Posted