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

This study has been completed.
Sponsor:
Collaborators:
North Central Cancer Treatment Group
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00002872
First received: November 1, 1999
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Biological: bleomycin sulfate
Drug: doxycycline
Other: talc
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: A PROSPECTIVE RANDOMIZED TRIAL OF BLEOMYCIN VS. DOXYCYCLINE VS. TALC FOR THE INTRAPLEURAL TREATMENT OF MALIGNANT PLEURAL EFFUSIONS

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Estimated Enrollment: 480
Study Start Date: November 1996
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Compare intrapleural bleomycin vs. doxycycline vs. talc in the treatment of malignant pleural effusion with respect to time to recurrence of the effusion. II. Compare these treatments with respect to the necessity for further treatment of recurrent effusions. III. Compare these treatments with respect to the extent of postinfusion complications, including pain and dyspnea. IV. Compare these treatments with respect to duration of chest tube or soft catheter drainage required following pleurodesis. V. Compare these treatments with respect to duration of hospitalization for retreatment of malignant pleural effusion following recurrence. VI. Compare these treatments with respect to survival. VII. Compare these treatments with respect to the impact of the procedure on pain and dyspnea.

OUTLINE: This is a randomized trial. Patients are stratified by type of drainage device and participating institution. All patients are randomized to undergo pleurodesis with bleomycin, doxycycline, or talc by indwelling pleural catheter. A second procedure is undertaken 72 hours later if pleural drainage is persistently large. Patients are followed monthly for survival.

PROJECTED ACCRUAL: A total of 480 patients will be entered over 48 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002872

Sponsors and Collaborators
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Investigators
Study Chair: John C. Ruckdeschel, MD H. Lee Moffitt Cancer Center and Research Institute
Study Chair: Randolph S. Marks, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002872     History of Changes
Other Study ID Numbers: CDR0000065154, E-8592, NCCTG-942853, NCI-P96-0076
Study First Received: November 1, 1999
Last Updated: August 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
malignant pleural effusion

Additional relevant MeSH terms:
Neoplasm Metastasis
Pleural Effusion
Pleural Effusion, Malignant
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Pleural Diseases
Pleural Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bleomycin
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimalarials
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014