Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma - Full Text View

Sponsor:	British Thoracic Society
Collaborator:	Medical Research Council
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00030459

Purpose

RATIONALE: Palliative therapy may help patients with advanced cancer live more comfortably. It is not yet known if palliative therapy is more effective with or without chemotherapy in treating patients who have malignant mesothelioma.

PURPOSE: Randomized phase II trial to compare the effectiveness of palliative therapy with or without different chemotherapy regimens in treating patients who have malignant mesothelioma.

Condition	Intervention	Phase
Malignant Mesothelioma	Drug: cisplatin Drug: mitomycin C Drug: vinblastine sulfate Drug: vinorelbine tartrate	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma

Resource links provided by NLM:

MedlinePlus related topics: Mesothelioma Palliative Care

Drug Information available for: Mitomycin Cisplatin Vinorelbine Vinorelbine tartrate Vinblastine sulfate Vinblastine Mitomycins

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 2000

Detailed Description:

OBJECTIVES:

Determine the feasibility of palliative therapy alone versus palliative therapy with mitomycin, vinblastine, and cisplatin versus palliative therapy with vinorelbine in patients with malignant mesothelioma.
Determine the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms.

Arm I: Patients receive palliative therapy alone comprising non-chemotherapeutic therapy (e.g., radiotherapy, painkillers, steroids, relaxants, and special pain relief techniques).
Arm II: Patients receive palliative therapy as in arm I and chemotherapy comprising mitomycin IV (courses 1, 2, and 4 only), vinblastine IV, and cisplatin IV over 4 hours on day 1. Chemotherapy repeats every 21 days for a total of 4 courses.
Arm III: Patients receive palliative therapy as in arm I and chemotherapy comprising vinorelbine IV over 5 minutes once weekly on weeks 1-6 and 9-14.

Quality of life is assessed at baseline for all patients; at weeks 3, 6, 9, and 12 for arm I; at weeks 4, 7, 10, and 13 for arm II; at weeks 3, 6, 10, and 13 for arm III; at weeks 21 and 29, and then every 8 weeks thereafter for all patients.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 1 year.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Immunohistochemically or cytologically confirmed malignant mesothelioma
- Epithelial and other histological types
Symptomatic pleural effusion allowed if treated and controlled by drainage, pleurodesis, or pleurectomy
Prior surgical resection allowed if stable or progressive disease by 2 CT scan measurements at least 6 weeks apart

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

WHO 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC greater than 3,000/mm3
Neutrophil count greater than 1,500/mm3
Platelet count greater than 100,000/mm3

Hepatic:

Not specified

Renal:

Not specified

Other:

Considered medically fit to receive chemotherapy
No other disease or prior malignancy that would preclude study
No clinical evidence of infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for mesothelioma

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030459

Locations

United Kingdom
Princess Royal Hospital
Hull, England, United Kingdom, HU8 9HE
Leeds Teaching Hospital Trust
Leeds, England, United Kingdom, LS1 3EX
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Medical Research Council Clinical Trials Unit
London, England, United Kingdom, NW1 2DA
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Stobhill General Hospital
Glasgow, Scotland, United Kingdom, G21 3UW
Dorothy House Foundation
Bradford-Onavon, United Kingdom, BA15 2LE
St. Peters Hospital
Chertsey Surrey, United Kingdom, KT 16 OPZ

Sponsors and Collaborators

British Thoracic Society

Medical Research Council

Investigators

Study Chair:	Martin F. Muers, MD	Leeds General Infirmary
Study Chair:	David J. Girling, MD	Medical Research Council

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00030459 History of Changes
Other Study ID Numbers:	CDR0000069167, BTS-MESO-1, MRC-BTS-MESO-1, EU-20134
Study First Received:	February 14, 2002
Last Updated:	February 26, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma

Additional relevant MeSH terms:

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Mitomycins
Mitomycin
Vinorelbine
Cisplatin
Vinblastine
Antibiotics, Antineoplastic
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on February 09, 2012