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Lung CancerPhase 2NCT00389688

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

A Phase 2 study testing cisplatin, pemetrexed disodium and adjuvant therapy in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
cisplatin, pemetrexed disodium and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
13 participants
Where
1 siteBelgium
Study dates
Aug 2006to Jul 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

Other trials in Belgium

About this study

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)

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.

Read the 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.

Conditions
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful treatment delivery

  2. Toxicity (no grade 4) during chemotherapy

Secondary outcomes (7)

  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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionJul 2008

Why it stopped: low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389688
Sponsor's protocol ID
EORTC-08051
Other IDs
EORTC-08051, 2005-003822-25, 2005
Status last verified
Jul 2012
First submitted
18 Oct 2006
Last updated
18 Jul 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, pemetrexed disodium and adjuvant therapy in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful treatment delivery. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00389688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.

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