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
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Arm A-Vinorelbine
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
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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).
Other Names:
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Arm B-Pemetrexed
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
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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)
Other Names:
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are eligible to be included in the study only if they meet all of the following criteria:
- Patients with completely resected stage IB (> 4 cm), II, or IIIA Non-Squamous NSCLC. Patient must be enrolled and begin therapy within 4 to 12 weeks from the date of complete surgical resection.
- Fresh tissue must be available for genomics expression profiling.
- ECOG performance status of 0 or 1.
- NO prior chemotherapy, radiation therapy, or biologic/targeted therapy within the last 5 years. Prior therapy with low dose methotrexate or similar medications is allowed if therapy used to treat non-malignant conditions.
- Age ≥ 18 years.
- No previous or concomitant malignancy in the past 5 years other than curatively-treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin.
- No other serious medical or psychiatric illness.
- Signed informed consent.
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Required laboratory data within one week of enrollment:
- ANC or AGC ≥ 1500 per uL;
- Platelets ≥ 100,000 per uL;
- Total bilirubin ≤ 1.5 mg/dL;
- Creatinine ≤ 2 mg/dL; creatinine clearance ≥ 45 mL/min;
- SGOT/SGPT ≤ 1.5x ULN.
- Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post menopause) must test negative for pregnancy within 7 days prior to or at the time of enrollment based on a serum pregnancy test. Both sexually active males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and their health care team, during the study and for 3 months following the last dose of study drug.
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
- Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Concurrent administration of any other anti-tumor therapy (see #4 inclusion for exceptions).
- Inability to comply with protocol or study procedures.
- Active infection requiring IV antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- Major surgery (other than definitive lung cancer surgery) within two weeks of study or other serious concomitant systemic disorders that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
- Myocardial infarction having occurred less than 6 months before inclusion, any known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications.
- Contraindication to corticosteroids.
- Inability or unwillingness to take folic acid or vitamin B12 supplementation.
- Unwillingness to stop taking herbal supplements while on study.
- Presence of clinically significant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry and throughout study enrollment as the distribution of pemetrexed in this fluid space is not fully understood.
- Inability to discontinue administration of aspirin at a dose > 1300 mg/day or other long acting, non-steroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents such as piroxicam). Moderate dose ibuprofen may be continued.
- Female patients that are pregnant or breast-feeding.

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 | |
Presbyterian HealthCare | |
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 |
Publications:
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT00545948 |
Other Study ID Numbers: |
Pro00000657 |
First Posted: | October 18, 2007 Key Record Dates |
Results First Posted: | June 9, 2014 |
Last Update Posted: | July 21, 2014 |
Last Verified: | June 2014 |
Non-Small-Cell Lung Cancer NSCLC Non-Squamous Genomics |
Guided Therapy Directed Therapy Genomic Expression Profiles Chemotherapy Sensitivity |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Cisplatin |
Pemetrexed Vinorelbine Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |