Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have mesothelioma of the lung.

Detailed Description
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OBJECTIVES: Determine the proportion of patients with potentially resectable mesothelioma of the pleura remaining operable after treatment with neoadjuvant cisplatin and gemcitabine. Determine the response rate and overall survival of patients treated with this regimen. Determine the tolerability of this regimen in these patients. Determine the number of postoperative hospitalization days and occurrence and duration of surgical complications in patients treated with this regimen. Determine the quality of life of patients treated with this regimen. Compare the proportion of patients who report psychological distress at 3 months after surgery vs at study registration. OUTLINE: Patients receive cisplatin IV on day 1 and gemcitabine IV on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses. Within 6 weeks after completion of chemotherapy, patients undergo restaging by CT scan followed by surgical resection. Quality of life is assessed at baseline, day 1 of course 3, within 4 weeks after surgery, and then at 3 and 6 months. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.

Official Title
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Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura

Conditions
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Malignant Mesothelioma

Intervention / Treatment
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* Drug: cisplatin
* Drug: gemcitabine hydrochloride
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically and clinically confirmed pleural mesothelioma Stages T1-3, N0-2, M0 by CT scan of the chest Mediastinoscopy required for staging of mediastinal lymph nodes Considered completely resectable PATIENT CHARACTERISTICS: Age: Over 18 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No severe liver disease Renal: Creatinine no greater than 1.7 mg/dL Cardiac: Adequate cardiac function No cardiac disease that would preclude forced hydration or surgery Pulmonary: Predicted postoperative FEV_1 greater than 1 by spirometry Other: No contraindication to surgery No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer No uncontrolled infection No uncontrolled diabetes No neurologic or psychiatric disorders that would preclude study compliance No other serious illnesses that would preclude study participation No other circumstances that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery No prior pleurectomy or lung resection except for diagnostic purposes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: gemcitabine hydrochloride|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IA malignant mesothelioma, stage IB malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma