Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Pleural Effusion

Neoplasm Metastasis

Pleural Effusion, Malignant

Pleural Diseases

Respiratory Tract Diseases

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

docetaxel

therapeutic thoracoscopy

David R. Jones, MD

RATIONALE: Giving drugs, such as docetaxel, directly into the pleura after surgery to drain the pleural effusion may help keep fluid from building up again.

PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of intrapleural docetaxel given after surgery in patients with malignant pleural effusion.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of intrapleural docetaxel in patients with malignant pleural effusion.

Secondary

* Determine the toxicity profile of this drug in these patients.
* Determine the pharmacokinetics of this drug in plasma and pleural fluid from these patients.
* Determine the response in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients undergo thorascopic surgery to drain the malignant pleural effusion. An intrapleural catheter (Pleurx catheter) is then inserted for subsequent docetaxel instillation. Approximately 24 hours after surgery, patients receive docetaxel intrapleurally over 3 minutes via the Pleurx catheter. The Pleurx catheter is then clamped for 4 hours and the patient is placed in several different positions to ensure uniform distribution of docetaxel throughout the pleural cavity.

Cohorts of 3-6 patients receive escalating doses of intrapleural docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed at weeks 1 and 3 and then monthly thereafter.

PROJECTED ACCRUAL: Approximately 8-24 patients will be accrued for this study.

Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion

Phase I Trial of Intrapleural Docetaxel Administered Via an Implantable Catheter in Subjects With a Malignant Pleural Effusion

National Cancer Institute (NCI)

University of Virginia

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients undergo video-assisted thoracic surgery (VATS) lobectomy, which requires 3 small incisions on the side of the chest. The entire anatomic pulmonary lobe is removed, as well as all peribronchial lymph nodes and anterior hilar lymph nodes. If it is not possible to remove the lobe using the VATS approach, then 1 of the incisions is converted to a standard thoracotomy. Patients are followed every 4 months for the first 2 years, and then every 6 months for the next 3 years.

video-assisted surgery

Scott J. Swanson, MD

John R. Roberts, MD, MBA

RATIONALE: Video-assisted surgery may be an effective treatment and have fewer side effects than conventional surgery in patients with non-small cell lung cancer.

PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery in treating patients who have non-small cell lung cancer.

OBJECTIVES: I. Determine the feasibility of performing video-assisted thoracic surgery (VATS) lobectomy, without significant morbidity or perioperative mortality, in patients with small (no greater than 3.0 cm), peripheral, non-small cell lung cancer. II. Determine the rate at which a thoracotomy must be carried out to complete a VATS lobectomy in these patients. III. Describe the complications associated with this procedure. IV. Describe the length of the operative procedure, duration of chest tube stay, and length of hospitalization in this patient population. V. Describe the survival and failure-free survival, over a 5-year period, in this patient population following this procedure.

OUTLINE: Patients undergo video-assisted thoracic surgery (VATS) lobectomy, which requires 3 small incisions on the side of the chest. The entire anatomic pulmonary lobe is removed, as well as all peribronchial lymph nodes and anterior hilar lymph nodes. If it is not possible to remove the lobe using the VATS approach, then 1 of the incisions is converted to a standard thoracotomy. Patients are followed every 4 months for the first 2 years, and then every 6 months for the next 3 years.

PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 3 years.

Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer

Video-Assisted Lobectomy for Peripheral (no Greater Than 3 cm), N0, Non-Small Cell Lung Cancer: A Phase II Feasibility Study

Eastern Cooperative Oncology Group

Alliance for Clinical Trials in Oncology

Rare Diseases

Recurrence

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Malignant Mesothelioma

Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.

Patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results.

talc

therapeutic videothoracoscopy

Robert Winter, MD

RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of the chest cavity may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not yet known which therapy is more effective in treating pleural effusion caused by malignant mesothelioma.

PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.

OBJECTIVES:

Primary

* Compare the effectiveness of video-assisted thoracoscopic cytoreductive pleurectomy vs talc pleurodesis, in terms of 1-year survival, in patients with suspected or proven malignant mesothelioma.

Secondary

* Compare the control of pleural effusion in these patients.
* Compare procedure-related complications in these patients.
* Compare the symptoms and quality of life of these patients at 3, 6, and 12 months after treatment.
* Compare the length of hospital stay for these patients.
* Compare the exercise tolerance of these patients at 3, 6, and 12 months after treatment.
* Determine the cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (high vs low). Patients are randomized to 1 of 2 treatment arms.

* Arm I (video-assisted thoracoscopic \[VAT\] cytoreductive pleurectomy): Patients undergo VAT cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.
* Arm II (talc pleurodesis): Patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results.

Quality of life, complications, and resource use are assessed at baseline and at 1, 3, 6, and 12 months.

Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma

Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma

Papworth Hospital NHS Foundation Trust

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion	NCT00114205	Metastatic Canc...	docetaxel therapeutic tho...	18 Years -	National Cancer Institute (NCI)
Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer	NCT00003692	Lung Cancer	therapeutic tho... video-assisted ...	18 Years -	Alliance for Clinical Trials in Oncology
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma	NCT00821860	Malignant Mesot... Metastatic Canc...	talc therapeutic tho... therapeutic vid...	18 Years -	Papworth Hospital NHS Foundation Trust
Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer	NCT00003692	Lung Cancer	therapeutic tho... video-assisted ...	18 Years -	Alliance for Clinical Trials in Oncology
Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion	NCT00114205	Metastatic Canc...	docetaxel therapeutic tho...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for therapeutic thoracoscopy