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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | September 1995 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001450 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | 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 ICMJE | Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC |
| 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. |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Safety/Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 58 |
| Completion Date | June 2000 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001450 |
| Responsible Party | |
| Study ID Numbers ICMJE | 950198, 95-C-0198 |
| Study Sponsor ICMJE | National Cancer Institute (NCI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | July 1999 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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