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Pemetrexed Disodium and Cisplatin Before or After Surgery in Treating Patients With Stage IB or Stage II Non-Small Cell Lung Cancer That Can be Removed by Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00389688
Recruitment Status : Terminated (low accrual)
First Posted : October 19, 2006
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective before or after surgery in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying the side effects of pemetrexed disodium and cisplatin and comparing how well they work when given before or after surgery in treating patients with stage IB or stage II non-small cell lung cancer that can be removed by surgery.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: pemetrexed disodium Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Detailed Description:



  • 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 regimen.
  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Pemetrexed and Cisplatin as Either Induction or Adjuvant Chemotherapy in Stage IB-II Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : August 2006
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Successful treatment delivery
  2. Toxicity (no grade 4) during chemotherapy

Secondary Outcome Measures :
  1. Overall toxicity (all grades)
  2. Progression-free survival and overall survival
  3. Overall clinical response rate (neoadjuvant chemotherapy arm)
  4. Pathologic complete response (neoadjuvant chemotherapy arm)
  5. Resectability rate (neoadjuvant chemotherapy arm)
  6. Surgical morbidity and mortality
  7. Fraction of patients that actually receives chemotherapy (adjuvant chemotherapy arm)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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 [G-CSF])
  • No aspirin or nonsteroidal anti-inflammatory drugs within 5 days before or after chemotherapy
  • No other concurrent experimental treatments
  • No other concurrent anticancer treatments

Information from the National Library of Medicine

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 identifier (NCT number): NCT00389688

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Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Paul Germonpre, MD University Hospital, Antwerp
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00389688    
Other Study ID Numbers: EORTC-08051
2005-003822-25 ( EudraCT Number )
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors