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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2003 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on February 14, 2002. Last Updated on January 12, 2012 History of Changes

Sponsor:	Swiss Group for Clinical Cancer Research
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00030745

Purpose

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	Intervention	Phase
Malignant Mesothelioma	Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

June 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Weder W, Stahel RA, Bernhard J, Bodis S, Vogt P, Ballabeni P, Lardinois D, Betticher D, Schmid R, Stupp R, Ris HB, Jermann M, Mingrone W, Roth AD, Spiliopoulos A; Swiss Group for Clinical Cancer Research. Multicenter trial of neo-adjuvant chemotherapy followed by extrapleural pneumonectomy in malignant pleural mesothelioma. Ann Oncol. 2007 Jul;18(7):1196-202. Epub 2007 Apr 11.

ClinicalTrials.gov Identifier:	NCT00030745 History of Changes
Other Study ID Numbers:	CDR0000069194, SWS-SAKK-17-00, EU-20136
Study First Received:	February 14, 2002
Last Updated:	January 12, 2012
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IA malignant mesothelioma
stage IB malignant mesothelioma
stage II malignant mesothelioma
stage III malignant mesothelioma

Additional relevant MeSH terms:

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 09, 2012