Search / Trial NCT00001499

Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients With Stage III Non-Small Cell Lung Cancer

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Carcinoma Combination Chemotherapy Combined Modality Therapy Infusion Intravenous Lung Neoplasm Non Small Cell Lung Cancer

Description

This is a Phase II study of paclitaxel administered as a 96-hour (4 day) continuous infusion with a bolus of cisplatin followed by chest radiotherapy for previously untreated patients with stage III non-small cell lung cancer (NSCLC). The non-small cell lung cancer tissue obtained prior to the start of treatment will be studied for mutations of the p53 gene. The goal of this phase II study is to determine the response rate to 4 cycles of infusional paclitaxel and bolus cisplatin for patients with stage III NSCLC. The response will again be assessed following completion of 6000 cGy of chest ...

Gender

All

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed non-small cell lung cancer of the following histologies: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, No mixed small/non-small cell carcinoma with predominant small cell component.
  • Unresectable stage IIIA/B disease confined to thorax including:
  • Microscopic disease involvement following attempted surgery and limited to anatomic areas corresponding to stage III disease (N2-3, T3-4).
  • Surgically treated stage I/II disease with histologic or cytologic proof of relapse and limited to anatomic areas corresponding to stage III disease (N2-3, T3-4).
  • T3, N0 tumor extending directly to the chest wall considered resectable and not eligible.
  • No stage IIIB disease with pleural effusion visible on chest x-ray unless related to a previous thoracotomy.
  • No typical carcinoid or mesothelioma.
  • Measurable disease preferred but not required.
  • PRIOR/CONCURRENT THERAPY:
  • No prior chemotherapy or thoracic radiotherapy.
  • PATIENT CHARACTERISTICS:
  • Age: 18 and over.
  • Performance status: ECOG 0-2.
  • Hematopoietic:
  • AGC greater than 2,000.
  • Platelets greater than 100,000.
  • Hepatic: Bilirubin no greater than 1.5 mg/dL.
  • Renal: Creatinine no greater than 1.5 mg/dL.
  • Cardiovascular:
  • No symptomatic heart disease including: Less than fully compensated congestive cardiac failure, Significant arrhythmias e.g.: Greater than first-degree heart block, Uncontrolled and symptomatic atrial dysrhythmia except sinus, bradycardia or sustained ventricular tachycardia, Myocardial infarction within 3 months.
  • Pulmonary: No major uncontrolled active infection (unless due to obstructed bronchus).
  • OTHER:
  • No major active psychiatric problem requiring hospitalization or psychotropic medication such as phenothiazines.
  • No prior second malignancy within 5 years except: nonmelanomatous skin cancer, In situ carcinoma of the cervix.
  • No pregnant or nursing women.

Attachments

readout_NCT00001499_2024-03-02.pdf

4.5 MB

NCT00001499_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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