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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01211275
Other study ID # NL25655.031.08
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 27, 2010
Last updated February 27, 2017
Start date May 22, 2009
Est. completion date May 6, 2013

Study information

Verified date February 2017
Source The Netherlands Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date May 6, 2013
Est. primary completion date November 13, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Antoni van Leeuwenhoekziekenhuis (NKI-AVL) Amsterdam Noord-Holland

Sponsors (2)

Lead Sponsor Collaborator
The Netherlands Cancer Institute Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 the side effects of the standard chemotherapy and the additional risks related to axitinib use hypertension, fatigue, abdominal discomfort AE;SAE;SUSAR
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