A Phase II Study of the Association of Glivec® Plus Gemzar® in Patients With Unresectable, Refractory, Malignant Mesothelioma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Gruppo Italiano MEsotelioma.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Gruppo Italiano MEsotelioma
Information provided by:
Gruppo Italiano MEsotelioma
ClinicalTrials.gov Identifier:
NCT00551252
First received: October 29, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Mesothelioma |
Drug: Imatinib mesylate plus Gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of the Association of Glivec® (Imatinib Mesylate, Formerly Known as STI 571) Plus Gemzar® (Gemcitabine) in Patients With Unresectable, Refractory, Malignant Mesothelioma Expressing Either PDGFR-Beta or C-Kit |
Resource links provided by NLM:
Further study details as provided by Gruppo Italiano MEsotelioma:
Primary Outcome Measures:
- Overall response rate [ Time Frame: Every two months ]
Secondary Outcome Measures:
- Progression-free-survival; Overall Survival; Safety [ Time Frame: Follow-up after end of treatment will be every three months; safety will be analyzed throughout the whole study ]
| Estimated Enrollment: | 56 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: I |
Drug: Imatinib mesylate plus Gemcitabine
Imatinib (400 mg daily) + Gemcitabine (500 mg/sqm, days 1 and 8 every 21 days) for a maximum of 6 cycles
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Uncontrolled active infections
- Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551252
Contacts
| Contact: Camillo Porta, MD | +39-0382-501355 | c.porta@smatteo.pv.it |
Locations
| Italy | |
| Medical Oncology, IRCCS San Matteo University Hospital Foundation | Not yet recruiting |
| Pavia, Italy, 27100 | |
| Principal Investigator: Camillo Porta, MD | |
Sponsors and Collaborators
Gruppo Italiano MEsotelioma
Investigators
| Principal Investigator: | Camillo Porta, MD | Medical Oncology, IRCCS San Matteo University Hospital Foundation, pavia, Italy |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00551252 History of Changes |
| Other Study ID Numbers: | GIMe/01/06 |
| Study First Received: | October 29, 2007 |
| Last Updated: | October 29, 2007 |
| Health Authority: | Italy: Ethics Committee |
Additional relevant MeSH terms:
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Gemcitabine Imatinib Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013