Back to resultsPilot Study Investigating the Metabolic Activity and Transcriptional Profiling in Vivo in Tumor Biopsies in Melanoma Patients During Treatment With Pazopanib Alone and in Combination With Paclitaxel
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Pazopanib/Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
Inclusion criteria:
- Age ≥ 18 years
- Diagnosis of histologically or cytologically confirmed melanoma stage III or IV.
- Fresh tumor tissue must be provided for all subjects for biomarker analysis before (within 14 days prior to treatment start) and during (on day 10 of the pazopanib monotherapy and the last day of the treatment with pazopanib, day 70) treatment with investigational product (asservation in RNAlater, for kryo asservation, and for cell cultures)
- Assessable metastases (skin or superficial lymph nodes with a minimal diameter 1 cm)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ system function
Exclusion criteria:
- Prior malignancy.
- Central nervous system (CNS) metastases
- Corrected QT interval (QTc) > 480 msecs using Bazett's formula.
History of any one or more of the following cardiovascular conditions within the past 6 months:
- Cardiac angioplasty or stenting;
- Myocardial infarction;
- Unstable angina;
- Coronary artery bypass graft surgery;
- Symptomatic peripheral vascular disease;
- Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
- Poorly controlled hypertension
- History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- Presence of uncontrolled infection
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
- Evidence of active bleeding or bleeding diathesis
- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
- Prior exposure to the study drug pazopanib
Sites / Locations
- University Hospital Zurich, Division of Dermatology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pazopanib/Paclitaxel
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of metabolic activity in vivo
The primary efficacy objective is to evaluate the metabolic activity in vivo through standardising the uptake value (SUV) in the FDG-PET/CT in comparison of the SUV between baseline, after pazopanib alone (day 10) and after pazopanib plus paclitaxel (day 70).
Secondary Outcome Measures
Determination of changes in gene expression profiling
Determination of changes in gene expression profiling on exon level in all patients with (sub)-cutaneous or superficial lymph node metastases (of melanoma) during pazopanib and pazopanib plus paclitaxel therapy in comparison to pretreatment profile
Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS)
Changes in S100 and LDH during therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01666418
Brief Title
Pilot Study Investigating the Metabolic Activity and Transcriptional Profiling in Vivo in Tumor Biopsies in Melanoma Patients During Treatment With Pazopanib Alone and in Combination With Paclitaxel
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
5. Study Description
Brief Summary
This is an open, monocentric, pilot study to determine the metabolic activity (glucose-uptake) in vivo during monotherapy with pazopanib in comparison to combination therapy with pazopanib plus paclitaxel and to investigate the transcriptional profile of cutaneous melanoma metastasis before and during the therapy (pazopanib vs. pazopanib plus paclitaxel) in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy.
Primary Objective:
Evaluation of metabolic activity in vivo
Secondary Objective:
Determination of changes in gene expression profiling Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS). Changes in S100 and LDH during therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH)
Trial with medicinal product
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pazopanib/Paclitaxel
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Pazopanib/Paclitaxel
Primary Outcome Measure Information:
Title
Evaluation of metabolic activity in vivo
Description
The primary efficacy objective is to evaluate the metabolic activity in vivo through standardising the uptake value (SUV) in the FDG-PET/CT in comparison of the SUV between baseline, after pazopanib alone (day 10) and after pazopanib plus paclitaxel (day 70).
Time Frame
84 days ( Baseline, Day 10, Day 70)
Secondary Outcome Measure Information:
Title
Determination of changes in gene expression profiling
Description
Determination of changes in gene expression profiling on exon level in all patients with (sub)-cutaneous or superficial lymph node metastases (of melanoma) during pazopanib and pazopanib plus paclitaxel therapy in comparison to pretreatment profile
Time Frame
84 days ( Baseline, Day 10, Day 70)
Title
Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS)
Time Frame
112 days
Title
Changes in S100 and LDH during therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH)
Time Frame
84 days ( Baseline, Day 10, Day 70)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Age ≥ 18 years
Diagnosis of histologically or cytologically confirmed melanoma stage III or IV.
Fresh tumor tissue must be provided for all subjects for biomarker analysis before (within 14 days prior to treatment start) and during (on day 10 of the pazopanib monotherapy and the last day of the treatment with pazopanib, day 70) treatment with investigational product (asservation in RNAlater, for kryo asservation, and for cell cultures)
Assessable metastases (skin or superficial lymph nodes with a minimal diameter 1 cm)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ system function
Exclusion criteria:
Prior malignancy.
Central nervous system (CNS) metastases
Corrected QT interval (QTc) > 480 msecs using Bazett's formula.
History of any one or more of the following cardiovascular conditions within the past 6 months:
Cardiac angioplasty or stenting;
Myocardial infarction;
Unstable angina;
Coronary artery bypass graft surgery;
Symptomatic peripheral vascular disease;
Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
Poorly controlled hypertension
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
Presence of uncontrolled infection
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
Evidence of active bleeding or bleeding diathesis
Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
Prior exposure to the study drug pazopanib
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhard Dummer, Professor MD
Organizational Affiliation
University Hospital Zurich, Division of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Dermatology
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Pilot Study Investigating the Metabolic Activity and Transcriptional Profiling in Vivo in Tumor Biopsies in Melanoma Patients During Treatment With Pazopanib Alone and in Combination With Paclitaxel
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