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

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paclitaxel
cisplatin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Chemotherapy, In Vitro Testing, Infusional, Lung Neoplasm, Pharmacokinetics

Eligibility Criteria

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

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.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001450
Brief Title
Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC
Official Title
Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
July 1999
Overall Recruitment Status
Completed
Study Start Date
September 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed 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 study of the relationship between in vitro drug sensitivity, achievable plasma concentrations of paclitaxel, and patients' response to therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Keywords
Chemotherapy, In Vitro Testing, Infusional, Lung Neoplasm, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
58 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
cisplatin

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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