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Home > "C" Clinical Trials Conditions > Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-small Cell Lung Cancer  Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-small Cell Lung Cancer
Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer,psychosocial effects/treatment
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 65 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AminahJatoi, Study Chair, North Central Cancer Treatment Group
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Quain & Ramstad Clinic, P.C.
Bismark, North Dakota, 58501
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Ann Arbor Hematology Oncology
Ypsilanti, Michigan, 48197
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Additional Information:
Study ID Numbers: CDR0000067656; NCCTG-N9921
Study Start Date: January 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005059
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
2. Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
3. Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
4. Vinorelbine and/or Gemcitabine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
5. Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other Iowa Clinical Trials
Other Cedar Rapids Clinical Trials
Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-small Cell Lung Cancer
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