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Adjuvant Chemotherapy of Pemetrexed/Carboplatin Compared With Vinorelbine/Carboplatin in Patients With Completely Resected NSCLC

18 Years
80 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

Adjuvant Chemotherapy of Pemetrexed/Carboplatin Compared With Vinorelbine/Carboplatin in Patients With Completely Resected NSCLC

Pemetrexed, a multi-target folate antimetabolite, shows clear activity in non-small cell
lung cancer (NSCLC). In a phase III study for patients with previously treated advanced
NSCLC, the efficacy of single-agent pemetrexed, as determined by overall survival, was
similar to that of docetaxel. (Hanna et al, 2004) The combination of carboplatin and
pemetrexed has been of particular interest because it has demonstrated both good efficacy
and a tolerable side effect profile. Phase I studies evaluated pemetrexed plus carboplatin
in patients with malignant pleural mesothelioma, showed the regimen was efficacious and well
tolerated. (Hughes et al, 2002) The combination of oxaliplatin and pemetrexed was compared
with carboplatin and pemetrexed as first-line therapy for advanced NSCLC in a randomized
phase II study. Response rates were 27 and 33%, respectively, and not statistically
different. Toxicity in the carboplatin/pemetrexed arm was low, this doublet can be delivered
easily and is well tolerated. Dose reductions occur only in 3.7% cycles. (Scagliotti et al,
2005) Therefore, it seems reasonable to test a less toxic regimen in patients with NSCLC
after complete (R0) resection of the tumor, where reduced toxicities might improve the
feasibility of drug delivery, compliance and the convenience of treatment for the patient
and hence perhaps improve survival. The main purpose of this randomized phase II trial is to
evaluate the clinical feasibility and activity of administering adjuvant chemotherapy of
pemetrexed/carboplatin compared with vinorelbine/carboplatin in patients with completely
resected NSCLC.

Inclusion Criteria:

- Patients with completely resected stage IB (>4 cm), II, or IIIA non-squamous NSCLC.
Patient must be enrolled and begin therapy within 4-6 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.

- Required laboratory data within one week of enrollment: a)ANC or AGC ≥ 1500 per uL;
b)Platelets ≥ 100,000 per uL; c)Total bilirubin ≤ 1.5 mg/dL; d)Creatinine < 2 mg/dL;
creatinine clearance ≥ 45 mL/min; e)SGOT/SGPT ≤ 1.5× 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:

- 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.

- 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

- 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.

- 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.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

To determine the clinical feasibility rate (CFR) of 4 cycles of adjuvant chemotherapy with Pemetrexed and Carboplatin vs. Vinorelbine and Carboplatin

Outcome Description:

To determine the clinical feasibility rate (CFR) of 4 cycles of adjuvant chemotherapy with Pemetrexed and Carboplatin vs. Vinorelbine and Carboplatin in patients with NSCLC stage IB, IIA, IIB and T3N1 (without need for further radiotherapy). Treatment is considered to have clinical feasibility if dose limiting toxicity (DLT) will not be observed, and no non-acceptance by the patient leading to premature withdrawal, and no death due to cancer or cancer therapy will occur.

Outcome Time Frame:

1 month

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

August 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Pemetrexed
  • Vinorelbine
  • Carboplatin
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms