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

NCT00030745 | Completed Phase 2 DMC

• 3 other identifiers: SAKK 17/00SWS-SAKK-17-00EU-20136
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Mesothelioma

Keywords

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

Interventions

cisplatin DRUG

gemcitabine hydrochloride DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (1)

UniversitaetsSpital

Zurich, CH-8091, Switzerland

Location

Related Publications (1)

• 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. doi: 10.1093/annonc/mdm093. Epub 2007 Apr 11.

  PMID: 17429100 RESULT

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Rolf A. Stahel, MD

  UniversitaetsSpital Zuerich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: June 1, 2000
• Primary Completion: May 1, 2003
• Study Completion: August 1, 2003
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

CH (1)