Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

This study has been completed.
Sponsor:
Collaborator:
Supported by grants J3-3021 and J3-6044 from the Ministry of Higher Education, Science and Technology of the Republic of Slovenia
Information provided by:
Institute of Oncology Ljubljana
ClinicalTrials.gov Identifier:
NCT01243632
First received: November 10, 2010
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in mesothelioma patients. However, median survival of this patient group was only about 12 months. With intent to find more effective treatment the investigators performed phase II study with gemcitabine in low dose (130-250 mg/m2) in 6-hours (prolonged) infusion in combination with cisplatin in advanced non-small cell lung cancer (Zwitter et al. Anticancer Drugs 2005;16:1129-34). After favourable experience, the investigators decided to explore such regiment in patients with malignant pleural mesothelioma (MPM) as well.


Condition Intervention Phase
Malignant Pleural Mesothelioma
Drug: Prolonged 6-hr infusion of gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Low-dose Gemcitabine in Prolonged Infusion and Cisplatin in Treatment of Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by Institute of Oncology Ljubljana:

Primary Outcome Measures:
  • Response rate [ Time Frame: Computerized tomography (CT) measurement of disease will be performed after 2nd cycle of chemotherapy and at the end of the treatment ] [ Designated as safety issue: No ]
    Efficacy of the treatment will be measured by response rate (RR) and disease control rate (DCR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for assessment of response in malignant pleural mesothelioma


Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed by monitoring the adverse events during treatment and follow-up phase and graded according the NCI Common Toxicity Criteria (CTC), version 2.0. Participants will be followed until death or 2 to 7 years (average 4.5 years).


Enrollment: 78
Study Start Date: December 2002
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Prolonged 6-hr infusion of gemcitabine
    Gemcitabine 250 mg/m2 in prolonged 6 hr infusion on day 1 and 8, and cisplatin at 75 mg/m2 on day 2 of 3 week cycle, for 4-6 cycles
Detailed Description:

The purpose of this study is to evaluate new regimen of treatment for its activity in malignant pleural mesothelioma (MPM). The primary objectives of the trial are assessing the treatment toxicity, response rate, and progress free survival; secondary objectives are assessment of overall survival and quality of life.

Inclusion criteria:

  • Biopsy-proven diagnosis of MPM
  • Inoperable for anatomic or physiological reason
  • Measurable and previously unirradiated lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2
  • Adequate haematopoietic, liver, and kidney function.
  • Signed informed consent for participation in the trial

Exclusion criteria:

  • Significant medical co-morbidity
  • Pregnant or lactating women
  • History of the cancer in the previous 10 years or breast cancer ever.

The general treatment schedule will be identical for all patients: gemcitabine in 6-hours infusion on days 1 and 8, and cisplatin at 75 mg/m2 on day 2 of a 3-weekly cycle with standard antiemetic treatment using metoclopramide, dexamethasone, aprepitant, and granisetron. After 4 cycles, patients not in progression and without serious toxicity continued with additional 2 cycles of monotherapy with gemcitabine in prolonged infusion.

National Cancer Institute Common Toxicity Criteria (NCI CTC), version 2.0 will be used for grading the toxicity. In the day of administration of the cytotoxic drug complete blood cell count and chemistry panel will be performed, and the treatment will be reduced or avoided in the event of bone marrow suppression or decline in renal clearance. In cases of Grade I (NCI CTC, vs. 2.0) neutropenia and/or thrombocytopenia, the dose of gemcitabine will be reduced to 75%; the drug will be omitted with Grade II or greater neutro/thrombocytopenia. Cisplatin will be omitted in cases of Grade ≥ II nephrotoxicity and/or grade III nausea or vomiting.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy-proven diagnosis of malignant pleural mesothelioma
  • Inoperable for anatomic or physiological reason
  • Measurable and previously unirradiated lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2
  • Adequate haematopoietic, liver, and kidney function.
  • Signed informed consent for participation in the trial

Exclusion Criteria:

  • Significant medical co-morbidity
  • Pregnant or lactating women
  • History of the cancer in the previous 10 years or breast cancer ever.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243632

Locations
Slovenia
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Institute of Oncology Ljubljana
Supported by grants J3-3021 and J3-6044 from the Ministry of Higher Education, Science and Technology of the Republic of Slovenia
Investigators
Study Director: Matjaz Zwitter, MD, PhD Institute of Oncology Ljubljana
  More Information

No publications provided

Responsible Party: Viljem Kovac, MD, Head of the Mesothelioma Team, Institute of Oncology Ljubljana
ClinicalTrials.gov Identifier: NCT01243632     History of Changes
Other Study ID Numbers: 86/12/02
Study First Received: November 10, 2010
Last Updated: November 17, 2010
Health Authority: Slovenia: Ethics Committee

Keywords provided by Institute of Oncology Ljubljana:
malignant pleural mesothelioma
chemotherapy
gemcitabine
cisplatin
long infusion

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014