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Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma (N08CPA)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT01211275
First received: September 27, 2010
Last updated: February 27, 2017
Last verified: February 2017
  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

Condition Intervention Phase
Malignant Pleural Mesothelioma Biological: axitinib Drug: chemotherapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • To test the impact of the addition of axitinib to standaard chemotherapy treatment on histology samples [ Time Frame: micro-vessel density;expression of VEGF and PDGF receptor; extent of necrosis and apoptosis ]
    To determine the effects of the addition of axitinib to standard chemotherapy on tissue samples with respect to micro-vessel density (MVD); expression of VEGF-Receptor; PDGF receptor expression; extent of necrosis and apoptosis


Secondary Outcome Measures:
  • the side effects of the standard chemotherapy and the additional risks related to axitinib use [ Time Frame: AE;SAE;SUSAR ]
    hypertension, fatigue, abdominal discomfort


Enrollment: 32
Actual Study Start Date: May 22, 2009
Study Completion Date: May 6, 2013
Primary Completion Date: November 13, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm 2
axitinib + cisplatin + premetrexed
Biological: axitinib
axitinib: 5 mg BID, day 2 until day 21 of each cycle; cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
Other Names:
  • cisplatin
  • alimta
Active Comparator: arm 1
cisplatin + premetrexed
Drug: chemotherapy
cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
Other Names:
  • cisplatin
  • alimta

Detailed Description:

To determine the effects of the addition of axitinib to standard chemotherapy on tissue samples with respect to micro-vessel density (MVD): expression of VEGF-Receptor; PDGF receptor expression; extent of necrosis and apoptosis.

To determine the safety of the addition of axitinib (to a maximum of the recommended dose of maximally 2 x 10 mg per day) to the standard treatment with cisplatin and pemetrexed.

To determine the feasibility of performing a (second) thoracoscopy after 10 weeks of the combination treatment with cisplatin, pemetrexed and axitinib.

Serum samples will be collected and tested for inhibiting effects in a tube formation and spheroid sprouting assay.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01211275

Locations
Netherlands
Antoni van Leeuwenhoekziekenhuis (NKI-AVL)
Amsterdam, Noord-Holland, Netherlands, 1066 CX
Sponsors and Collaborators
The Netherlands Cancer Institute
Pfizer
Investigators
Principal Investigator: P Baas, Dr. NKI-AvL
  More Information

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT01211275     History of Changes
Other Study ID Numbers: NL25655.031.08
Study First Received: September 27, 2010
Last Updated: February 27, 2017

Keywords provided by The Netherlands Cancer Institute:
mesothelioma
chemotherapy
translational research
axitinib

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin
Pemetrexed
Axitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 25, 2017