Axitinib in Malignant Mesothelioma (N08CPA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by The Netherlands Cancer Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT01211275
First received: September 27, 2010
Last updated: September 28, 2010
Last verified: September 2010

September 27, 2010
September 28, 2010
May 2009
September 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01211275 on ClinicalTrials.gov Archive Site
the side effects of the standard chemotherapy and the additional risks related to axitinib use [ Time Frame: AE;SAE;SUSAR ] [ Designated as safety issue: Yes ]
hypertension, fatigue, abdominal discomfort
Same as current
Not Provided
Not Provided
 
Axitinib in Malignant Mesothelioma
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

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 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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Pleural Mesothelioma
  • 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:
    • axitinib
    • cisplatin
    • alimta
  • Drug: chemotherapy
    cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
    Other Names:
    • cisplatin
    • alimta
  • Experimental: arm 2
    axitinib + cisplatin + premetrexed
    Intervention: Biological: axitinib
  • Active Comparator: arm 1
    cisplatin + premetrexed
    Intervention: Drug: chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: P. Baas, Dr. +31 (0)20-5122958 p.baas@nki.nl
Contact: W. A. Buikhuisen, MD +31 (0)20-5122958 w.buikhuisen@nki.nl
Netherlands
 
NCT01211275
NL25655.031.08
No
Dr. P. Baas, Netherlands Cancer Institute/Antoni van Leeuwenhoekziekenhuis (NKI-AVL)
The Netherlands Cancer Institute
Pfizer
Principal Investigator: P Baas, Dr. NKI-AvL
The Netherlands Cancer Institute
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP