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NCT Number: NCT01243632

Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

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.

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Key information

Conditions

Malignant Pleural Mesothelioma Adenoma Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prolonged 6-hr infusion of gemcitabine

Drug

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

Primary outcomes

  1. 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

    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 outcomes

  1. Safety and tolerability

    Time frame: During the study

    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).

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Collaborators

  • Ministry of Higher Education, Science and Technology, Solvenia

Registry information

Official study title

A Phase II Trial of Low-dose Gemcitabine in Prolonged Infusion and Cisplatin in Treatment of Malignant Pleural Mesothelioma

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Nov 18, 2010
Registry last updated
Nov 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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