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Randomized Phase II Study of Pemetrexed and Cisplatin as Either Induction or Adjuvant Chemotherapy in Stage IB-II Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Randomized Phase II Study of Pemetrexed and Cisplatin as Either Induction or Adjuvant Chemotherapy in Stage IB-II Non-Small Cell Lung Cancer (NSCLC)



- Compare the tolerability (in terms of drug delivery and toxicity) of neoadjuvant vs
adjuvant chemotherapy comprising cisplatin and pemetrexed disodium in patients with
resectable stage IB or II non-small cell lung cancer.


- Determine the overall toxicity of this regimen in these patients.

- Determine the progression-free and overall survival of patients treated with this

- Determine the overall clinical response rate, pathologic complete response, and
resectability rate in patients treated with neoadjuvant chemotherapy.

- Determine the surgical morbidity and mortality of patients treated with these regimens.

- Determine the fraction of patients in the adjuvant arm that receives chemotherapy.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to institution, histological subtype (squamous vs nonsquamous) and clinical stage
(IB vs II). Patients are randomized to 1 of 2 treatment arms.

- Arm I (neoadjuvant chemotherapy): Patients receive cisplatin IV over 3-6 hours and
pemetrexed disodium IV on day 1. Treatment repeats every 21 days for up to 3 courses in
the absence of disease progression or unacceptable toxicity. Four to six weeks after
completion of chemotherapy, patients undergo surgery.

- Arm II (adjuvant chemotherapy): Patients undergo surgery. Beginning 4-8 weeks after
surgery, patients receive cisplatin and pemetrexed disodium as in arm I.

After completion of study treatment, patients are followed periodically for 5 years and then
annually thereafter.

PROJECTED ACCRUAL: A total of 132 patients will be accrued for this study.

Inclusion Criteria


- Pathologically confirmed non-small cell lung cancer (NSCLC)

- Stage IB or II disease

- Resectable disease

- At least 1 measurable lesion

- No mediastinal involvement by mediastinoscopy and/or positron emission tomography
with fludeoxyglucose F 18 scan

- No evidence of metastatic disease


- WHO performance status 0-2

- Absolute neutrophil count > 1,500/mm³

- Platelet count > 100,000/mm³

- Hemoglobin > 10 g/dL

- Creatinine clearance ≥ 60 mL/min

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 3.0 times ULN

- AST and ALT ≤ 3.0 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignant disease, except for the following:

- Basocellular carcinoma of the skin

- Adequately treated carcinoma in situ of the cervix

- Low-grade prostate cancer

- Other cancer for which the patient has been disease-free for ≥ 5 years

- No congestive heart failure or angina pectoris unless medically controlled

- No myocardial infarction within the past 6 months

- No uncontrolled hypertension or arrhythmia

- No active uncontrolled infection requiring antibiotics

- No illness or medical condition that would preclude study participation

- No pre-existing motor or sensory neurotoxicity ≥ grade 2


- No prior surgery for NSCLC

- No prior or other concurrent chemotherapy for NSCLC

- No prior or concurrent radiotherapy for NSCLC

- No concurrent immunotherapy

- No concurrent targeted agents

- No concurrent hormonal cancer therapy

- No concurrent routine colony-stimulating factor (e.g., prophylactic filgrastim

- No aspirin or nonsteroidal anti-inflammatory drugs within 5 days before or after

- No other concurrent experimental treatments

- No other concurrent anticancer treatments

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Successful treatment delivery

Safety Issue:


Principal Investigator

Paul Germonpre, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Universitair Ziekenhuis Antwerpen


United States: Federal Government

Study ID:




Start Date:

August 2006

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms