Adjuvant Cisplatin With Either Genomic-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small-Cell Lung Cancer (TOP0703)
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|ClinicalTrials.gov Identifier: NCT00545948|
Recruitment Status : Terminated (Study terminated due to reproducibility issues with genomics prediction model.)
First Posted : October 18, 2007
Results First Posted : June 9, 2014
Last Update Posted : July 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Vinorelbine followed by Cisplatin Drug: Pemetrexed followed by Cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Prospective Study Evaluating the Role of Directed Cisplatin Based Chemo With Either Vinorelbine or Pemetrexed for the Adj Tx of Early Stage NSCLC in Patients Using Genomic Expression Profiles of Chemo Sensitivity to Guide Therapy|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
Drug: Vinorelbine followed by Cisplatin
Vinorelbine 25 mg/m2 IV over 6-10 minutes on days 1 and 8, followed by Cisplatin 75 mg/m2 IV over 60 minutes on day 1 (every 21 days x 4 cycles).
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
Drug: Pemetrexed followed by Cisplatin
Pemetrexed 500 mg/m2 IV infusion over approximately 10 minutes on day 1, followed by Cisplatin 75 mg/m2 IV over 60 min on day 1 (every 21 days x 4 cycles)
- 2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC [ Time Frame: 2 years ]Progression-free survival time was defined as the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The two-year progression free survival rate is a percentage, representing the fraction of treated patients who, after two years, are disease free or alive.
- Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy [ Time Frame: 4 years ]The percentage of patients with completely resected NSCLC tumors who had successful genomic analysis and assigned to treatment among patients. All 31 patients enrolled in the study had completely resected tumors. These tumors included a mixture of squamous and non-squamous histologies as indicated the original protocol. However, an amendment dated January 25, 2010 limited eligibility to patients with non-squamous disease. Given that only 5 patients were accrued into the study after this amendment, results reported will consider all histologies.
- 2-Year Overall Survival in Patients Treated for NSCLC [ Time Frame: 2 years ]Overall survival time was defined as the time from initiation of study treatment to the date of death as a result of any cause. Time was censored at the date of the last follow-up visit for patients who were still alive. The two-year overall survival rate is a percentage, representing the fraction of treated patients who, after two years, are alive
- Patient Understanding and Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for Adjuvant Treatment of Early Stage Lung Cancer [ Time Frame: Baseline ]Do to space limitations, see the Detailed Description in the study protocol for the wording of the questions used in the Patient Expectations Questionnaire.
- Compare Drug Sensitivity Patterns of Cisplatin and Pemetrexed in Both Treatment Arms [ Time Frame: 2 years ]Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity. There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545948
|United States, Florida|
|Palm Beach Cancer Institute|
|West Palm Beach, Florida, United States, 33401|
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28204|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Maria Parham Hospital|
|Henderson, North Carolina, United States, 27536|
|Scotland HealthCare System (Scotland Memorial Hospital)|
|Laurinburg, North Carolina, United States, 28352|
|Southeastern Regional Medical Center, Gibson Cancer Center|
|Lumberton, North Carolina, United States, 28358|
|Duke Raleigh Hospital|
|Raleigh, North Carolina, United States, 27609|
|Johnston Memorial Hospital Authority|
|Smithfield, North Carolina, United States, 27577|
|Columbus County Hospital|
|Whiteville, North Carolina, United States, 28472|
|United States, South Carolina|
|Beaufort Memorial Hospital|
|Beaufort, South Carolina, United States, 29902|
|Coastal Cancer Center|
|Myrtle Beach, South Carolina, United States, 29572|
|United States, Virginia|
|Community Memorial Health Center|
|South Hill, Virginia, United States, 23970|
|Principal Investigator:||Neal Ready, Ph.D., M.D.||Duke University Medical Center, Hematology/Oncology, Duke Cancer Institute|