Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-Small Cell Lung Cancer
|First Received Date ICMJE||April 6, 2000|
|Last Updated Date||February 6, 2009|
|Start Date ICMJE||January 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005059 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-Small Cell Lung Cancer|
|Official Title ICMJE||A Phase II Study of Carboplatin and Paclitaxel in Elderly Patients With Metastatic or Recurrent Unresectable Non-Small Cell Lung Cancer|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating patients who have metastatic or recurrent unresectable non-small cell lung cancer.
OBJECTIVES: I. Determine the response rate to carboplatin and paclitaxel in elderly patients with metastatic or recurrent unresectable non-small cell lung cancer. II. Determine the toxicity of this regimen in these patients. III. Determine if the hypothesized lack of social support impacts the recruitment of elderly patients into clinical trials. IV. Determine if a previously validated tool of functional status in the elderly predicts treatment related toxicity superior to that predicted by the ECOG performance status in this patient population.
OUTLINE: Following completion of the Lubben Social Network Scale and Frailty Questionnaire, patients receive carboplatin IV over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses. Patients with complete response receive 2 additional courses of therapy. Patients with partial response or stable disease may receive additional courses of therapy at investigator's discretion. Patients are followed every 3 months for 5 years or until disease progression.
PROJECTED ACCRUAL: A total of 49 patients will be accrued for this study over 27 months.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Lung Cancer|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||49|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage IV disease OR Recurrent unresectable disease No other conventional curative or significant palliative therapies available Measurable disease At least one lesion a minimum of one dimension in diameter of at least 20 mm No symptomatic and/or untreated CNS metastases
PATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 3 times upper limit of normal Renal: Creatinine clearance at least 40 mL/min Other: No uncontrolled infection No uncontrolled seizure disorder No uncontrolled diabetes mellitus No other malignancies within the past 3 years except adequately treated basal or squamous cell skin cancer or noninvasive carcinomas
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic or immunotherapy for recurrent or metastatic disease No concurrent biologic therapy Chemotherapy: No prior chemotherapy for recurrent or metastatic disease except as radiosensitizer No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for recurrent or metastatic disease except as adjuvant therapy At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow No concurrent radiotherapy except for CNS therapy Surgery: See Disease Characteristics At least 3 weeks since prior major surgery
|Ages||65 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00005059|
|Other Study ID Numbers ICMJE||CDR0000067656, NCCTG-N9921|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||North Central Cancer Treatment Group|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||June 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP