Brief Title
Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung
Official Title
Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura
Brief Summary
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
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Malignant Mesothelioma
Intervention
cisplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
61
Start Date
June 2000
Completion Date
August 2003
Primary Completion Date
May 2003
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Rolf A. Stahel, MD, ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT00030745
Organization ID
SAKK 17/00
Secondary IDs
SWS-SAKK-17-00
Responsible Party
Sponsor
Study Sponsor
Swiss Group for Clinical Cancer Research
Study Sponsor
Rolf A. Stahel, MD, Study Chair, UniversitaetsSpital Zuerich
Verification Date
May 2012