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Clinical Trial Details

NCT ID: NCT01211275
Date Last Changed: September 28, 2010

Overview

Research Study Summary

A Phase 1/Phase 2 clinical study for patients with Malignant Pleural Mesothelioma

Research Study Title

A Randomized Phase I/II Study of Standard Chemotherapy (Cisplatin and Pemetrexed) With or Without Axitinib in Patients With Malignant Mesothelioma: Interim Biopsy Analysis to Determine Efficacy

Purpose

The purpose of this study is to investigate the effects of axitinib, a potent angiogenesis inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients with mesothelioma

To Learn more

Recruitment Details

Phase
1/2
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
The Netherlands Cancer Institute
Duration
16 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • histologically or cytologically diagnosed malignant mesothelioma

  • age > 18 years

  • Medically suitable for limited surgical intervention (pleural biopsies or limited pleurectomy)

  • Measurable or evaluable disease is not required

  • Ability to understand the study and give signed informed consent including the approval to accept a second thoracoscopic or surgical treatment after the third course

  • No previous chemotherapy

  • Radiotherapy is allowed when this is given for palliation, the interval is > 4 weeks, not more than 1/3 of the bone marrow capacity or all tumor is within the irradiation field.

  • WHO performance status = < 2

  • Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:

Hematology:

  • ANC= > 1.5 x 109/L,

  • Platelets= > 150 x 109/L,

  • Hemoglobin = > 6,0 mmol/l

Chemistry:

  • total serum bilirubin < UNL;

  • AST and ALT= < 2.5xUNL,

  • AP < 5xUNL (unless bone metastases are present in the absence or any liver disease)

  • Serum creatinine = < 2xUNL

Exclusion Criteria:

  • Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency

  • Previous successful pleurodesis

  • Uncontrolled hypertension

  • Symptomatic peripheral neuropathy = > grade 2 according to NCIC CTC,version 3.0

  • Presence of symptomatic CNS metastases

  • Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition

  • Concomitant administration to any other experimental drugs under investigation

  • Impaired renal function

Site Locations (1)

Country State City Zip Facility and Contact
Netherlands Noord-Holland Amsterdam 1066 CX Antoni van Leeuwenhoekziekenhuis (NKI-AVL)
P Baas, Dr.
+31 (0)20-5122958
p.baas@nki.nl

P Baas, Dr.
Principal Investigator

Contact

P. Baas, Dr.
+31 (0)20-5122958
E-mail:

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