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Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Pleural Mesothelioma

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ClinicalTrials.gov Identifier: NCT02303899
Recruitment Status : Completed
First Posted : December 1, 2014
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Tracking Information
First Submitted Date  ICMJE November 19, 2014
First Posted Date  ICMJE December 1, 2014
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2014)
anti-tumor activity of Imatinib mesylate in combination with Gemcitabine [ Time Frame: 12 weeks ]
assess the anti-tumor activity of Imatinib mesylate in combination with Gemcitabine, in terms of 3-months progression-free survival (PFS) rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2014)
  • anti-tumor activity of Imatinib mesylate in combination with Gemcitabine in terms of Response Evaluation Criteria In Solid Tumors (RECIST) criteria [ Time Frame: 16 weeks ]
    assess anti-tumor activity of Imatinib Mesylate (IM) in combination with GEM, in terms of objective response rate according to RECIST criteria (Modified RECIST criteria for MPM), and duration of response
  • anti-tumor activity of Imatinib mesylate in combination with Gemcitabine in terms of overall survival (OS). [ Time Frame: 30 months ]
    assess anti-tumor activity of IM in combination with GEM, in terms of overall survival (OS).
  • safety profile of the combination according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3 [ Time Frame: 16 weeks ]
    determine the safety profile of the combination according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3
  • molecular profile of patients [ Time Frame: baseline ]
    evaluate the molecular profile of patients enrolled with Ion PGM Torrent Next-generation Sequencing platform correlating the molecular profiles identified with clinical characteristics and survival data of patients.
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 Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Pleural Mesothelioma
Official Title  ICMJE A Phase II Study of the Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Malignant Pleural Mesothelioma
Brief Summary This is a phase II, monocentric study of the combination of gemcitabine and imatinib mesylate in pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by Immunohistochemistry (IHC). Treatment will be done until disease progression, or patient refusal or withdrawal of patient consent, or unacceptable toxicity
Detailed Description

Pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by IHC will receive chemotherapy as follow :

  • Gemcitabine 1000 mg/m2, i.v., days 3 and 10 of a 21-days schedule;
  • Imatinib mesylate 400 mg/die orally on days 1-5 and 8-12 of a 21-days schedule.

Treatment repeats every 21 days in the absence of disease progression, patient refusal or withdrawal of patient consent, or unacceptable toxicity.

The molecular profile of patients enrolled will be evaluated with Ion Personal Genome Machine (PGM) Torrent Next-generation Sequencing platform in order to individuate potential predictive biomarkers and to improve the understanding of the molecular biology of these rare tumors. A correlation among the molecular profiles identified, clinical characteristics, and survival data of patients will be done

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mesothelioma, Malignant
Intervention  ICMJE
  • Drug: Gemcitabine
    infusion drug
    Other Name: Gemzar
  • Drug: Imatinib mesylate
    oral drug
    Other Name: Glivec
Study Arms  ICMJE Experimental: Gemcitabine & Imatinib mesylate
Gemcitabine 1000 mg/m2, i.v., days 3 and 10 of a 21-days schedule; Imatinib mesylate 400 mg/die orally on days 1-5 and 8-12 of a 21-days schedule.
Interventions:
  • Drug: Gemcitabine
  • Drug: Imatinib mesylate
Publications *

*   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: November 28, 2014)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age of > 18 years.
  2. Histologically proven malignant mesothelioma of the pleura or of the peritoneum, expressing PDGFR-beta and/or C-kit by immunohistochemistry.
  3. Locally advanced disease, unsuitable for curative surgical resection, or metastatic disease.
  4. Confirmed progression of the disease according to modified RECIST-criteria, documented after a pemetrexed-based chemotherapy.
  5. Eastern Cooperative Oncology group (ECOG) Performance Status of 0, 1 or 2.
  6. Life expectancy of at least 3 months.
  7. Written informed consent.

Exclusion Criteria:

  1. Co-existing tumors of different histologic origin, except non melanomatous localized skin cancer and/or in situ cervical carcinoma.
  2. A history of earlier tumors of different histologic origin being in complete remission for less than 5 years.
  3. Unresolved toxicity from prior antitumor treatment(s).
  4. Primary peritoneal mesothelioma.
  5. Any of the following abnormal baseline hematological values:

    • Hb < 9 g/dL
    • White blood count (WBC) < 3 x 109/L
    • Neutrophils < 1.5 x 109/L
    • Platelets < 100 x 109/L
    • Serum bilirubin > 2.5 mg/dL
    • Alanine transaminase (ALAT) and Aspartate transaminase (ASAT) > 3 x upper normal limit (UNL) (unless due to liver metastases)
    • Serum creatinine > 1.5 mg/dL.
  6. Symptomatic and/or unstable pre-existing brain metastases. To be enrolled in the study, subjects must have confirmation of stable disease by MRI or computer tomography (CT) scan within 4 weeks from day 1 of cycle 1 of treatment and have central nervous system (CNS) metastases well controlled by steroids, anti - epileptics or other symptom-relieving medications.
  7. Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or non compensated chronic heart disease in New York Heart Association (NYHA) class II or more.
  8. History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent.
  9. Pregnant or lactating women or inability/unwillingness to practice a medically approved method of contraception during study period (including 3 months following the end of treatment)
  10. Uncontrolled active infections.
  11. Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study.
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 Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02303899
Other Study ID Numbers  ICMJE ONC-2014-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: not planned
Responsible Party Istituto Clinico Humanitas
Study Sponsor  ICMJE Istituto Clinico Humanitas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
PRS Account Istituto Clinico Humanitas
Verification Date January 2021

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