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

NCT ID: NCT00030745

Last Updated: 2012-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2003-08-31

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.

Conditions

Malignant Mesothelioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rolf A. Stahel, MD

Role: STUDY_CHAIR

UniversitaetsSpital Zuerich

Locations

UniversitaetsSpital

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

PMID: 17429100 (View on PubMed)

Other Identifiers

SWS-SAKK-17-00

Identifier Type: OTHER

Identifier Source: secondary_id

EU-20136

Identifier Type: -

Identifier Source: secondary_id

SAKK 17/00

Identifier Type: -

Identifier Source: org_study_id