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

Swiss Group for Clinical Cancer Research

Status and phase

Completed

Phase 2

Conditions

Malignant Mesothelioma

Treatments

Drug: gemcitabine hydrochloride

Drug: cisplatin

Procedure: conventional surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT00030745

SWS-SAKK-17-00 (Other Identifier)

EU-20136

SAKK 17/00

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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