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

July 17, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Successful treatment delivery
Toxicity (no grade 4) during chemotherapy

Secondary Outcome Measures

Outcome Measure
Progression-free survival and overall survival
Overall toxicity (all grades)
Overall clinical response rate (neoadjuvant chemotherapy arm)
Pathologic complete response (neoadjuvant chemotherapy arm)
Resectability rate (neoadjuvant chemotherapy arm)
Surgical morbidity and mortality
Fraction of patients that actually receives chemotherapy (adjuvant chemotherapy arm)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Paul Germonpre, MD, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

October 18, 2006

First Submitted That Met QC Criteria

October 18, 2006

First Posted (ESTIMATE)

October 19, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-08051
  • 2005-003822-25 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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