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.

Condition	Treatment or Intervention	Phase
localized malignant mesothelioma	Drug: cisplatin  Drug: gemcitabine  Procedure: chemotherapy  Procedure: conventional surgery  Procedure: surgery	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Switzerland
      UniversitaetsSpital, Zurich,  CH-8091,  Switzerland

Study chairs or principal investigators

Rolf Arno Stahel, MD,  Study Chair,  UniversitaetsSpital   

Study ID Numbers:  CDR0000069194; SWS-SAKK-17/00; EU-20136
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  February 14, 2002
ClinicalTrials.gov Identifier:  NCT00030745
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08