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

Primary Purpose

Malignant Pleural Mesothelioma

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

axitinib

chemotherapy

About this trial

This is an interventional treatment trial for Malignant Pleural Mesothelioma focused on measuring mesothelioma, chemotherapy, translational research, axitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Antoni van Leeuwenhoekziekenhuis (NKI-AVL)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

arm 2

arm 1

Arm Description

axitinib + cisplatin + premetrexed

cisplatin + premetrexed

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

hypertension, fatigue, abdominal discomfort

Full Information

NCT ID

NCT01211275

First Posted

September 27, 2010

Last Updated

February 27, 2017

Sponsor

The Netherlands Cancer Institute

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01211275

Brief Title

Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma

Acronym

N08CPA

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

May 22, 2009 (Actual)

Primary Completion Date

November 13, 2012 (Actual)

Study Completion Date

May 6, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Netherlands Cancer Institute

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Pleural Mesothelioma

Keywords

mesothelioma, chemotherapy, translational research, axitinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

arm 2

Arm Type

Experimental

Arm Description

axitinib + cisplatin + premetrexed

Arm Title

arm 1

Arm Type

Active Comparator

Arm Description

cisplatin + premetrexed

Intervention Type

Biological

Intervention Name(s)

axitinib

Other Intervention Name(s)

cisplatin, alimta

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

chemotherapy

Other Intervention Name(s)

cisplatin, alimta

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

hypertension, fatigue, abdominal discomfort

Time Frame

AE;SAE;SUSAR

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

P Baas, Dr.

Organizational Affiliation

NKI-AvL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Antoni van Leeuwenhoekziekenhuis (NKI-AVL)

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1066 CX

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma

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