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

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ClinicalTrials.gov Identifier: NCT01211275
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : February 28, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Tracking Information
First Submitted Date  ICMJE September 27, 2010
First Posted Date  ICMJE September 29, 2010
Last Update Posted Date February 28, 2017
Actual Study Start Date  ICMJE May 22, 2009
Actual Primary Completion Date November 13, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2010)
the side effects of the standard chemotherapy and the additional risks related to axitinib use [ Time Frame: AE;SAE;SUSAR ]
hypertension, fatigue, abdominal discomfort
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Pleural Mesothelioma
Intervention  ICMJE
  • 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
  • Drug: chemotherapy
    cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
    Other Names:
    • cisplatin
    • alimta
Study Arms  ICMJE
  • Experimental: arm 2
    axitinib + cisplatin + premetrexed
    Intervention: Biological: axitinib
  • Active Comparator: arm 1
    cisplatin + premetrexed
    Intervention: Drug: chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2017)
32
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2010)
20
Actual Study Completion Date  ICMJE May 6, 2013
Actual Primary Completion Date November 13, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01211275
Other Study ID Numbers  ICMJE NL25655.031.08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Netherlands Cancer Institute
Study Sponsor  ICMJE The Netherlands Cancer Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: P Baas, Dr. NKI-AvL
PRS Account The Netherlands Cancer Institute
Verification Date February 2017

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