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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

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

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

The proposed study is a multi-center open label phase II study of the chemotherapy doublets
cisplatin/vinorelbine and cisplatin/pemetrexed as adjuvant therapy in early stage
non-squamous NSCLC.

Eligible patients will have no previous treatment for the current diagnosis of non-squamous
NSCLC. The two treatment groups of patients will be determined by gene expression profile
analysis of each patient's tumor: one group of vinorelbine-sensitive patients and one group
of pemetrexed-sensitive patients. The genomic expression profiling that will be utilized
generates a percentage for likelihood of chemotherapy sensitivity. Patients will be directed
to receive the chemotherapy regimen for which the percentage of predicted sensitivity is
highest. For instance, if the model predicted the likelihood of tumor sensitivity was 46% to
vinorelbine and 48% to pemetrexed, then the adjuvant chemotherapy would be directed to
cisplatin/pemetrexed. Patients whose tumors cannot be adequately analyzed for gene
expression will be offered adjuvant therapy off protocol as deemed appropriate by their
primary oncologist.

One hundred and seventeen patients with stage IB (> 4 cm), II or IIIA non-squamous NSCLC
will be enrolled. The vinorelbine-sensitive tumors group will receive Vinorelbine 25 mg/m2
days 1 and 8, followed by cisplatin 75 mg/m2 day 1, every 21 days for 4 cycles. The
pemetrexed-sensitive tumors group will receive pemetrexed 500 mg/m2 day 1 followed by
cisplatin 75 mg/m2 day 1, every 21 days for 4 cycles. Standard pre-medication regimens will
include dexamethasone, vitamin B12 and folate supplementation in the pemetrexed group.
Patients in both groups will receive up to a maximum of 4 cycles of therapy.

A pilot study is appropriate in this case because currently there is not a defined clinical
role for genomics technology in determining therapy for NSCLC. The two chemotherapy regimens
provided to the study patients are active agents in the treatment of non-squamous NSCLC.
Study treatment will consist of 4 cycles of chemotherapy.

Inclusion Criteria:

Patients are eligible to be included in the study only if they meet all of the following

1. 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.

2. Fresh tissue must be available for genomics expression profiling.

3. ECOG performance status of 0 or 1.

4. 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.

5. Age ≥ 18 years.

6. 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.

7. No other serious medical or psychiatric illness.

8. Signed informed consent.

9. 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.

10. 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:

1. Treatment within the last 30 days with a drug that has not received regulatory
approval for any indication at the time of study entry.

2. Concurrent administration of any other anti-tumor therapy (see #4 inclusion for

3. Inability to comply with protocol or study procedures.

4. Active infection requiring IV antibiotics, antifungal or antiviral agents, that in
the opinion of the investigator would compromise the patient's ability to tolerate

5. 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.

6. 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.

7. Contraindication to corticosteroids.

8. Inability or unwillingness to take folic acid or vitamin B12 supplementation.

9. Unwillingness to stop taking herbal supplements while on study.

10. 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.

11. 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.

12. Female patients that are pregnant or breast-feeding.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess if adjuvant chemotherapy using genomic expression profiles to direct sensitivity to vinorelbine or pemetrexed chemotherapy can increase two year disease-free survival rate in completely resected non-squamous NSCLC

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Neal Ready, Ph.D., M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Medical Center, Hematology/Oncology, Duke Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

June 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small-Cell Lung Cancer
  • Non-Squamous
  • Genomics
  • Guided Therapy
  • Directed Therapy
  • Genomic Expression Profiles
  • Chemotherapy Sensitivity
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Presbyterian Healthcare Charlotte, North Carolina  28233-3549
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Duke University Medical Center Durham, North Carolina  27710
University of Chicago Medical Center Chicago, Illinois  60637
Coastal Cancer Center Myrtle Beach, South Carolina  29572
Community Memorial Health Center South Hill, Virginia  23970-0090
Maria Parham Hospital Henderson, North Carolina  27536
Duke Raleigh Hospital Raleigh, North Carolina  27609
Scotland HealthCare System (Scotland Memorial Hospital) Laurinburg, North Carolina  28352
Southeastern Regional Medical Center, Gibson Cancer Center Lumberton, North Carolina  28358
Beaufort Memorial Hospital Beaufort, South Carolina  29902
Johnston Memorial Hospital Authority Smithfield, North Carolina  27577
Columbus County Hospital Whiteville, North Carolina  28472