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

Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00030745

Enrollment

Registered

2003-01-27

Start date

2000-06-30

Completion date

2003-08-31

Last updated

2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Mesothelioma

Keywords

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

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.

Interventions

DRUGcisplatin

DRUGgemcitabine hydrochloride

PROCEDUREconventional surgery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026