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Paclitaxel and Hyperthermic Perfusion in Treating Patients With Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

Primary Purpose

Lung Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
isolated perfusion
paclitaxel
hyperthermia treatment
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, limited stage small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, lung metastases, bronchoalveolar cell lung cancer, pulmonary carcinoid tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable primary lung cancer or pulmonary metastases that are unresectable on the basis of technical considerations or are sufficiently numerous that recurrent, potentially inoperable disease is highly probable Bilateral metastases allowed Unresectable bronchoalveolar carcinomas allowed Previously treated primary lung cancer allowed Disease outside confines of thorax allowed, provided bulk of disease in the chest is clearly the greatest threat to survival and/or extrathoracic disease is controlled No potentially treatable pulmonary metastases from lymphomas or germ cell tumors No biopsy proven interstitial fibrosis, radiation induced pneumonitis, or evidence of significant pulmonary hypertension by history, radiologic, echocardiographic, or catheterization studies No active intracranial or leptomeningeal metastases Prior resection or radiotherapy for intracranial metastases allowed if the following criteria are met: No active disease on 2 MRIs done one month apart No requirement for anticonvulsant medications or steroids Adequate pulmonary reserve to tolerate pneumonectomy: Oxygen consumption greater than 50% predicted AND FEV1 and DLCO greater than 80% predicted OR FEV1 or DLCO less than 80% predicted allowed if postoperative FEV1 and DLCO is at least 40% predicted on the basis of split function V/Q scan Prior radiotherapy to chest allowed provided 6 months have elapsed since completion of treatment and no history of, nor current evidence of, interstitial lung disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: Platelet count greater than 100,000/mm^3 Hemoglobin greater than 10 g/dL WBC greater than 3,500/mm^3 Hepatic: PT/PTT normal Bilirubin less than 1.5 times upper limit of normal (ULN) AST/ALT less than 1.5 times ULN Renal: Creatinine less than 1.6 mg/dL Cardiovascular: Fixed defects on thallium scanning with ejection fraction greater than 40% allowed Reversible or ischemic defects allowed only after cardiology clearance Pulmonary: See Disease Characteristics Resting oxygen saturation greater than 90% pCO_2 less than 45 mmHg by arterial blood gas Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infections HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: More than 30 days since prior biologic therapy for this malignancy Chemotherapy: More than 30 days since prior chemotherapy for this malignancy Prior paclitaxel allowed No prior bleomycin, nitrosoureas, or busulfan Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Prior thoracic surgery allowed

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • NCI - Center for Cancer Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
April 28, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00020007
Brief Title
Paclitaxel and Hyperthermic Perfusion in Treating Patients With Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
Official Title
A Phase I Study of Isolated Lung Perfusion With Paclitaxel and Moderate Hyperthermia in Patients With Unresectable Pulmonary Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Heating paclitaxel to several degrees above body temperature and infusing it to the affected area around the tumor may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel given by hyperthermic perfusion in treating patients with lung cancer or lung metastases that cannot be removed by surgery.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose and phase II dose of paclitaxel administered via hyperthermic retrograde isolated lung perfusion in patients with unresectable pulmonary malignancies. Determine the nature of the toxic effects of this regimen in this patient population. Evaluate the pharmacokinetic profile of this regimen in these patients. Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients. OUTLINE: This is a dose-escalation study of paclitaxel. Patients undergo posterolateral thoracotomy or median sternotomy. Patients receive paclitaxel over 90 minutes administered via hyperthermic retrograde isolated lung perfusion. The entire surgery lasts approximately 4 hours. Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 1 and 2 months. Patients with responding disease continue to be followed every 3 months. PROJECTED ACCRUAL: A maximum of 31 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Metastatic Cancer
Keywords
recurrent non-small cell lung cancer, limited stage small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, lung metastases, bronchoalveolar cell lung cancer, pulmonary carcinoid tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
isolated perfusion
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
hyperthermia treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable primary lung cancer or pulmonary metastases that are unresectable on the basis of technical considerations or are sufficiently numerous that recurrent, potentially inoperable disease is highly probable Bilateral metastases allowed Unresectable bronchoalveolar carcinomas allowed Previously treated primary lung cancer allowed Disease outside confines of thorax allowed, provided bulk of disease in the chest is clearly the greatest threat to survival and/or extrathoracic disease is controlled No potentially treatable pulmonary metastases from lymphomas or germ cell tumors No biopsy proven interstitial fibrosis, radiation induced pneumonitis, or evidence of significant pulmonary hypertension by history, radiologic, echocardiographic, or catheterization studies No active intracranial or leptomeningeal metastases Prior resection or radiotherapy for intracranial metastases allowed if the following criteria are met: No active disease on 2 MRIs done one month apart No requirement for anticonvulsant medications or steroids Adequate pulmonary reserve to tolerate pneumonectomy: Oxygen consumption greater than 50% predicted AND FEV1 and DLCO greater than 80% predicted OR FEV1 or DLCO less than 80% predicted allowed if postoperative FEV1 and DLCO is at least 40% predicted on the basis of split function V/Q scan Prior radiotherapy to chest allowed provided 6 months have elapsed since completion of treatment and no history of, nor current evidence of, interstitial lung disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: Platelet count greater than 100,000/mm^3 Hemoglobin greater than 10 g/dL WBC greater than 3,500/mm^3 Hepatic: PT/PTT normal Bilirubin less than 1.5 times upper limit of normal (ULN) AST/ALT less than 1.5 times ULN Renal: Creatinine less than 1.6 mg/dL Cardiovascular: Fixed defects on thallium scanning with ejection fraction greater than 40% allowed Reversible or ischemic defects allowed only after cardiology clearance Pulmonary: See Disease Characteristics Resting oxygen saturation greater than 90% pCO_2 less than 45 mmHg by arterial blood gas Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infections HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: More than 30 days since prior biologic therapy for this malignancy Chemotherapy: More than 30 days since prior chemotherapy for this malignancy Prior paclitaxel allowed No prior bleomycin, nitrosoureas, or busulfan Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Prior thoracic surgery allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S. Schrump, MD
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
NCI - Center for Cancer Research
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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Paclitaxel and Hyperthermic Perfusion in Treating Patients With Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

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