Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma

NCT01211275 | Completed Phase 1

• 1 other identifier: NL25655.031.08
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Pleural Mesothelioma

Keywords

mesothelioma; chemotherapy; translational research; axitinib

Outcome Measures

Primary Outcomes (1)

• To test the impact of the addition of axitinib to standaard chemotherapy treatment on histology samples

  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

  micro-vessel density;expression of VEGF and PDGF receptor; extent of necrosis and apoptosis

Secondary Outcomes (1)

• the side effects of the standard chemotherapy and the additional risks related to axitinib use

  AE;SAE;SUSAR

Study Arms (2)

arm 2

EXPERIMENTAL

axitinib + cisplatin + premetrexed

Biological: axitinib

arm 1

ACTIVE COMPARATOR

cisplatin + premetrexed

Drug: chemotherapy

Interventions

axitinib BIOLOGICAL

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.

Also known as: cisplatin, alimta

arm 2

chemotherapy DRUG

cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.

Also known as: cisplatin, alimta

arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Pfizer: collaborator

Study Sites (1)

Antoni van Leeuwenhoekziekenhuis (NKI-AVL)

Amsterdam, North Holland, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Mesothelioma, Malignant; Mesothelioma

Interventions

Axitinib; Cisplatin; Pemetrexed; Drug Therapy

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Therapeutics

Study Officials

• P Baas, Dr.

  NKI-AvL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 29, 2010
• Study Start: May 22, 2009
• Primary Completion: November 13, 2012
• Study Completion: May 6, 2013
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

NL (1)