Search / Trial NCT00001450

Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC

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

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Trial Information

Current as of March 05, 2024

Completed

Keywords

Chemotherapy In Vitro Testing Infusional Lung Neoplasm Pharmacokinetics

Description

This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in patients with advanced NSCLC. In addition, the plasma levels of paclitaxel will be measured, and the in vitro paclitaxel chemosensitivity of the tumor cells from as many patients as possible will be determined. This will allow further...

Gender

All

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed non-small cell lung cancer, including: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, Mixed histologies in the absence of a predominant small cell component.
  • Eligible Stages Include:
  • Stage IV, Stage IIIA/B ineligible for resection or radiotherapy, Postsurgical recurrence that is histologically or cytologically proven.
  • CNS Metastases Allowed Provided:
  • Radiotherapy completed prior to entry.
  • No requirement for concurrent steroids.
  • No carcinomatous meningitis.
  • No epidural metastases.
  • Measurable disease not required.
  • PRIOR/CONCURRENT THERAPY:
  • Biologic Therapy: Not specified.
  • Chemotherapy: No prior chemotherapy for lung cancer.
  • Endocrine Therapy: Not specified.
  • Radiotherapy: No prior chest irradiation for lung cancer.
  • Surgery: Prior surgery allowed.
  • PATIENT CHARACTERISTICS:
  • Age: 18 and over.
  • Performance Status: ECOG 0-2.
  • Hematopoietic:
  • Absolute granulocyte count greater than 2,000.
  • Platelet count greater than 100,000.
  • Hepatic: Bilirubin no greater than 1.5 mg/dL.
  • Renal: Creatinine no greater than 1.5 mg/dL.
  • Cardiovascular:
  • No CHF unless fully compensated.
  • No second- or third-degree heart block.
  • No uncontrolled, symptomatic atrial dysrhythmia except sinus bradycardia.
  • No sustained ventricular tachycardia.
  • No MI within 3 months.
  • OTHER:
  • No uncontrolled infection unless due to an obstructed bronchus.
  • No major psychiatric problems requiring hospitalization.
  • No psychotropic medications such as phenothiazines.
  • No contraindication to transfusion, if required.
  • No second malignancy within 5 years except: Nonmelanomatous skin cancer.
  • In situ cervical cancer.
  • No pregnant or nursing women.
  • Effective contraception required of fertile patients.

Attachments

readout_NCT00001450_2024-03-05.pdf

4.5 MB

NCT00001450_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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