NCT00551252

Brief Summary

The purpose of this study is to evaluate the antitumor activity of a combination of Imatinib mesylate and Gemcitabine in patients with unresectable malignant mesothelioma expressing either PDGFR-beta or C-kit

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 30, 2007

Status Verified

October 1, 2007

First QC Date

October 29, 2007

Last Update Submit

October 29, 2007

Conditions

Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    Every two months

Secondary Outcomes (1)

  • Progression-free-survival; Overall Survival; Safety

    Follow-up after end of treatment will be every three months; safety will be analyzed throughout the whole study

Study Arms (1)

I

EXPERIMENTAL
Drug: Imatinib mesylate plus Gemcitabine

Interventions

Imatinib mesylate plus GemcitabineDRUG

Imatinib (400 mg daily) + Gemcitabine (500 mg/sqm, days 1 and 8 every 21 days) for a maximum of 6 cycles

I

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of \> 18 years and \< 72 years
  • Patients with a histologically proven malignant mesothelioma of the pleura or of the peritoneum, expressing either PDFGR-beta or C-Kit by immunochemistry (ICH)
  • Locally advanced disease, unsuitable for curative surgical resection, or metastatic disease
  • Confirmed progression of the disease according to modified REcist-criteria, documented after a first-line, systemic (premetrex+cisplatin regimen) or local treatment (i.e., intrapleuric)
  • ECOG Performance Status of 0, 1 or 2
  • Life expectancy of at least 3 months
  • Capability of understanding the objectives of the study and giving written informed consent
  • Willingness and ability to comply with study requirements
  • Sufficient caloric and fluid intake, including patients under enteral or parenteral nutrition

You may not qualify if:

  • Co-existing tumors of different histologic origin, except non melanomatous localized skin cancer and/or in situ cervical carcinoma
  • A history of earlier tumors of different histologic origin being in complete remission since less than 5 years
  • Unresolved toxicity from prior antitumor treatment(s)
  • Primary peritoneal mesothelioma
  • Any of the following abnormal baseline hematological values:
  • Hb \< 9 g/dL
  • WBC \< 3 x 109/L
  • Neutrophils \< 1.5 x 109/L
  • Platelets \< 100 x 109/L
  • Serum bilirubin \> 2.5 mg/dL
  • ALAT and ASAT \> 3 x UNL (unless due to liver metastases)
  • Serum creatinine \> 1.5 mg/dL
  • 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 NYHA class II or more
  • History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent
  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Oncology, IRCCS San Matteo University Hospital Foundation

Pavia, 27100, Italy

Location

Related Publications (1)

  • Bertino P, Porta C, Barbone D, Germano S, Busacca S, Pinato S, Tassi G, Favoni R, Gaudino G, Mutti L. Preliminary data suggestive of a novel translational approach to mesothelioma treatment: imatinib mesylate with gemcitabine or pemetrexed. Thorax. 2007 Aug;62(8):690-5. doi: 10.1136/thx.2006.069872. Epub 2007 Feb 20.

    PMID: 17311837BACKGROUND

Related Links

MeSH Terms

Conditions

Mesothelioma

Interventions

Imatinib MesylateGemcitabine

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesDeoxycytidineCytidinePyrimidine Nucleosides

Study Officials

  • Camillo Porta, MD

    Medical Oncology, IRCCS San Matteo University Hospital Foundation, pavia, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Camillo Porta, MD

CONTACT

+39-0382-501355c.porta@smatteo.pv.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2007

First Posted

October 30, 2007

Study Start

January 1, 2008

Study Completion

December 1, 2009

Last Updated

October 30, 2007

Record last verified: 2007-10

Locations

IT(1)