Vinorelbine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
NCT ID: NCT00008333
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2001-04-30
2007-07-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of vinorelbine taken by mouth in treating older patients who have stage IIIB or stage IV non-small cell lung cancer.
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Detailed Description
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OUTLINE: Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed every 3 months for 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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vinorelbine
Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed every 3 months for 5 years.
vinorelbine tartrate
Interventions
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vinorelbine tartrate
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10.0 g/dL Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2 times upper limit of normal Other: No dysphagia or inability to swallow capsules intact No peripheral neuropathy grade 2 or greater No other significant medical condition that would preclude study No active infection within the past 2 weeks No other malignancy within the past 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this disease within the past 5 years Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 25% of bone marrow No prior radiotherapy to measurable lesion unless documented progression after therapy No concurrent radiotherapy, including palliative radiotherapy Surgery: At least 3 weeks since prior major surgery
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Aminah Jatoi, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Countries
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References
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Huschka MM, Mandrekar SJ, Schaefer PL, Jett JR, Sloan JA. A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials. Cancer. 2007 Feb 15;109(4):787-95. doi: 10.1002/cncr.22444.
Jatoi A, Hillman S, Stella P, Green E, Adjei A, Nair S, Perez E, Amin B, Schild SE, Castillo R, Jett JR; North Central Cancer Treatment Group. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol. 2005 Dec 20;23(36):9113-9. doi: 10.1200/JCO.2005.03.7465.
Kanard A, Jatoi A, Castillo R, Geyer S, Schulz TK, Fitch TR, Rowland KM, Nair S, Krook JE, Kugler JW. Oral vinorelbine for the treatment of metastatic non-small cell lung cancer in elderly patients: a phase II trial of efficacy and toxicity. Lung Cancer. 2004 Mar;43(3):345-53. doi: 10.1016/j.lungcan.2003.09.012.
Other Identifiers
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NCI-2012-02369
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000068398
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N0022
Identifier Type: -
Identifier Source: org_study_id
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