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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01666418
First received: August 8, 2012
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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

Condition Intervention Phase
Melanoma
Drug: Pazopanib/Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Evaluation of metabolic activity in vivo [ Time Frame: 84 days ( Baseline, Day 10, Day 70) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 84 days ( Baseline, Day 10, Day 70) ] [ Designated as safety issue: No ]
    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) [ Time Frame: 112 days ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01666418

Contacts
Contact: Jil Dreier jil.dreier@usz.ch
Contact: Reinhard Dummer, Professor, MD reinhard.dummer@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Dermatology Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Reinhard Dummer, Professor MD University Hospital Zurich, Division of Dermatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01666418     History of Changes
Other Study ID Numbers: SZ10ON01
Study First Received: August 8, 2012
Last Updated: August 15, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014