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

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ClinicalTrials.gov Identifier: NCT00030745
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

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.


Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: conventional surgery Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura
Study Start Date : June 2000
Actual Primary Completion Date : May 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030745


Locations
Switzerland
UniversitaetsSpital
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Rolf A. Stahel, MD UniversitaetsSpital Zuerich

Publications of Results:
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00030745     History of Changes
Other Study ID Numbers: SAKK 17/00
SWS-SAKK-17-00 ( Other Identifier: SAKK )
EU-20136
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Swiss Group for Clinical Cancer Research:
stage IA malignant mesothelioma
stage IB malignant mesothelioma
stage II malignant mesothelioma
stage III malignant mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs