Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions

NCT00002872 | Completed Phase 3

• 4 other identifiers: CDR0000065154E-8592NCCTG-942853NCI-P96-0076
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Some drugs such as bleomycin or doxycycline, or other compounds like talc, may help to control fluid in the chest caused by cancer. It is not yet known if bleomycin, doxycycline, or talc is more effective in treating patients with malignant pleural effusions. PURPOSE: Randomized phase III trial to compare the effectiveness of bleomycin, doxycycline, or talc in treating patients with malignant pleural effusions.

Conditions

Metastatic Cancer

Keywords

malignant pleural effusion

Interventions

bleomycin sulfate BIOLOGICAL

doxycycline DRUG

talc OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Cytologically confirmed unilateral malignant pleural effusion or exudative effusion with positive biopsy from any tumor type No chylous effusion Drainage of effusion with chest tube or soft catheter required Lung re-expansion demonstrated on chest x-ray Continuing drainage less than 250 mL/24 hours (or equivalent measured over 4 hours) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: (within 2 weeks prior to entry) WBC greater than 2,000 Platelets greater than 50,000 Hepatic: Not specified Renal: (within 2 weeks prior to entry) Creatinine less than 2.5 mg/dL OR Creatinine clearance greater than 40 mL/min Other: No pregnant or nursing women Adequate contraception required of fertile patients PRIOR CONCURRENT THERAPY: No prior sclerosing agents on the affected side No prior intrapleural therapy No change in systemic therapy for at least 2 weeks prior to randomization Biologic therapy: Not specified Chemotherapy: No prior systemic bleomycin Systemic chemotherapy allowed after pleurodesis Endocrine therapy: Hormone therapy allowed after pleurodesis Radiotherapy: No significant radiotherapy to affected hemithorax Irradiation of painful bone lesions allowed on the affected side if field does not include a significant portion of the pleura Surgery: See Disease Characteristics No prior thoracoscopic lysis of adhesions on the affected side

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• North Central Cancer Treatment Group: collaborator

MeSH Terms

Conditions

Neoplasm Metastasis; Pleural Effusion, Malignant

Interventions

Bleomycin; Doxycycline; Talc

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Magnesium Silicates; Magnesium Compounds; Inorganic Chemicals; Silicates; Minerals; Silicic Acid; Silicon Dioxide; Silicon Compounds

Study Officials

• John C. Ruckdeschel, MD

  H. Lee Moffitt Cancer Center and Research Institute

  STUDY CHAIR

• Randolph S. Marks, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 2, 2004
• Study Start: January 10, 1997
• Primary Completion: February 1, 2003
• Last Updated: June 22, 2023

Record last verified: 2023-06