Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung - Full Text View

Sponsored by:	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:	Treatment
Official Title:	Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma Surgery

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.

Study ID Numbers:	CDR0000069194, SWS-SAKK-17/00, EU-20136
Study First Received:	February 14, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00030745 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

localized malignant mesothelioma

Study placed in the following topic categories:

Antimetabolites
Radiation-Sensitizing Agents
Immunologic Factors
Cisplatin
Mesothelioma

Gemcitabine
Immunosuppressive Agents
Antiviral Agents
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Mesothelioma
Gemcitabine
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009