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Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma

Brief Summary

RATIONALE: Active symptom control may decrease chest pain, breathlessness, sweating, and general discomfort in patients with malignant pleural mesothelioma. It is not yet known if active symptom control is more effective with or without chemotherapy.

PURPOSE: This randomized phase III trial is studying active symptom control and chemotherapy to see how well they work compared to active symptom control alone in treating patients with malignant pleural mesothelioma.

Tracking Information
First Received DateJanuary 9, 2004
Last Changed DateAugust 6, 2013
Start DateSeptember 2003
Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Palliation of chest pain, breathlessness, malaise (e.g., feeling weak, tiredness, anorexia), and sweating attacks

Performance status as measured by WHO grade

Analgesic usage

Toxicity as measured by the NCIC CTC

Quality of life as assessed by the European Organization for Research and Treatment of Cancer

Tumor response as measured by the RECIST criteria

Progression-free survival as measured by CT scan

Descriptive Information
PhasePhase 3
Study TypeInterventional
Condition
  • Malignant Mesothelioma
Intervention
  • Drug: cisplatin
  • Drug: mitomycin C
  • Drug: vincristine sulfate
  • Drug: vinorelbine tartrate
  • Procedure: pain therapy
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
Detailed Description

OBJECTIVES:

Primary

- Compare the overall survival of patients with malignant pleural mesothelioma treated with active symptom control (ASC) alone vs ASC and mitomycin, vinblastine, and cisplatin vs ASC and vinorelbine.

Secondary

- Compare the toxic effects of these regimens in these patients.

- Compare symptom palliation (chest pain, breathlessness, malaise, and sweating attacks) in patients treated with these regimens.

- Compare the performance status of patients treated with these regimens.

- Compare analgesic usage in patients treated with these regimens.

- Compare the tumor response and progression-free survival of patients treated with these regimens.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients receive active symptom control (ASC) through regular visits at a specialist clinic. ASC may include steroids, analgesics, appetite stimulants, bronchodilators, and/or palliative radiotherapy, when required.

- Arm II: Patients receive ASC and chemotherapy comprising mitomycin IV, vincristine IV, and cisplatin IV on day 1. Chemotherapy repeats every 21 days for a total of 4 courses.

- Arm III: Patients receive ASC and vinorelbine IV over 5 minutes weekly for 6 weeks. Vinorelbine repeats every 55 days for a total of 2 courses.

Quality of life is assessed at baseline, every 3 weeks for 21 weeks, and then every 8 weeks thereafter.

Patients are followed at 15, 18, and 21 weeks, and then every 8 weeks thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 840 patients (280 per treatment arm) will be accrued for this study within 4 years.

Recruitment Information
Recruitment StatusCompleted
Anticipated Enrollment840
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

DISEASE CHARACTERISTICS:

- Histologically and immunohistochemically confirmed malignant pleural mesothelioma

- Epithelial and other histological types are allowed

- No more than 3 months since diagnosis

- Symptomatic pleural effusion must have been treated and brought under control by drainage, pleurodesis, or pleurectomy

- Prior surgical resection of mesothelioma allowed provided 2 CT scans at least 6 weeks apart show stable or progressive disease

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- WHO 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC > 3,000/mm^3

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

Hepatic

- Not specified

Renal

- Creatinine clearance > 50 mL/min

Pulmonary

- See Disease Characteristics

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Considered medically fit to receive chemotherapy

- No other disease or prior malignancy likely to interfere with protocol treatments or comparisons

- No clinical evidence of infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for mesothelioma

Endocrine therapy

- Not specified

Radiotherapy

- Prior local radiotherapy to a wound site after exploratory thoracotomy allowed

Surgery

- See Disease Characteristics

- See Radiotherapy

Administrative Information
NCTIDNCT00075699
SponsorMedical Research Council
Verification DateJune 2008
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