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Lung CancerPhase 2NCT00274898

Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer

A Phase 2 study testing celecoxib, docetaxel and adjuvant therapy in people with Lung Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 15 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, 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 to 75 years
Conditions the study is for
Lung Cancer
What is being tested?
celecoxib, docetaxel and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
80 participants
Where
15 sitesFrance
Study dates
May 2004to not given
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer meeting ≥ 1 of the following criteria:
  • Stage IIIB disease
  • Stage II or IIIA disease, meeting the following criteria:
  • Considered nonresectable
  • Pleural effusion present
  • Measurable disease
  • Must have received a prior regimen of radiotherapy and chemotherapy comprising docetaxel and carboplatin
  • Tumor volume must be able to be encompassed in the radiation field

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 12 weeks
  • Cardiac function compatible with radiotherapy
  • Neutrophil count ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.25 times ULN
  • AST and ALT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • No other malignancy in the past 10 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No active infection
  • No inflammatory bowel disease
  • No severe congestive heart failure
  • No severe hepatic disease defined as albumin < 25 g/L or Child-Pugh score ≥ 10
  • No severe renal disease defined as creatinine clearance < 30 mL/min
  • No known hypersensitivity to sulfonamides, the study or it's excipients, or polysorbate 80
  • No known hypersensitivity of NSAIDs, salicylic acid, or cyclo-oxygenase-2 inhibitors
  • No familial, social, geographical, or psychological condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 30 days since participation in another clinical study
  • More than 1 month since prior therapy for gastrointestinal ulcers
  • No concurrent fluconazole, ketoconazole, lithium, or dextromethorphan
  • No other concurrent anticancer treatment including chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic response modifier therapy
  • No concurrent aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Low-dose aspirin or NSAIDs for a duration of ≤ 1 week during the past 3 months allowed

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • Hopital Avicenne

    Bobigny, 93009

  • Centre Medical de Forcilles Hopital Prive

    Ferroles Attilly, 77150

  • Clinique du Petit Colmouilins

    Harfleur, 76700

  • Clinique Victor Hugo

    Le Mans, F-72000

  • Polyclinique des Quatre Pavillons

    Lormont, 33310

  • Centre de Radiotherapie et Oncologie Saint-Faron

    Mareuil-lès-Meaux, 77100

  • American Hospital of Paris

    Neuilly-sur-Seine, F-92202

  • Clinique De Valdegour

    Nîmes, 30900

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Tenon

    Paris, 75970

  • Clinique les Bleuets

    Reims, 51100

  • Polyclinique De Courlancy

    Reims, F-51100

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Centre Hospitalier Sud-Reiunion

    Saint-Pierre, 97448

  • Clinique Sainte Clotilde

    Sainte Clotilde, 97192

Other trials in France

About this study

Official title: Phase II Randomized Study Evaluting the Effect of Celecoxib as Maintenance Treatment of Stage IIIb Non-Small Cell Lung Cancer That Reponded or is Stable After Radiochemotherapy

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving celecoxib after radiation therapy and chemotherapy may kill any tumor cells that remain after radiation therapy and chemotherapy. Sometimes, after radiation therapy and chemotherapy, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to observation in treating patients who have undergone radiation therapy and chemotherapy for stage II or stage III non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the time to progression in patients with stage II-IIIB non-small cell lung cancer treated with celecoxib vs observation after treatment with chemoradiotherapy.

Secondary

  • Compare the 2-year survival rate of patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.
  • Compare weight changes and objective response in patients treated with these regimens.
  • Compare tolerability of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2), and total dose of radiotherapy (65 Gy vs 60 Gy).

All patients undergo radiotherapy 5 days a week for 7.5 weeks. Patients also receive docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Three weeks after the completion of radiotherapy, patients receive docetaxel alone IV over 30 minutes on days 1 and 22. Three weeks later, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients are observed every 3 months for 1 year and then every 6 months for 1 year.
  • Arm II: Patients receive oral celecoxib twice daily for up to 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 3 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Conditions
Lung Cancer
Being tested
celecoxib, docetaxel, adjuvant therapy, radiation therapy
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent 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. Time to progression

Secondary outcomes (5)

  1. 2-year survival rate

  2. Quality of life

  3. Weight changes

  4. Objective response

  5. Tolerability

Timeline

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

  1. First posted11 Jan 2006 (estimated)
  2. Study startMay 2004

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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00274898
Sponsor's protocol ID
CDR0000454352
Other IDs
GERCOR-B03-1, EU-20572, SANOFI-GERCOR-B03-1, PFIZER-GERCOR-B03-1
Status last verified
Sep 2006
First submitted
10 Jan 2006
Last updated
9 Feb 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing celecoxib, docetaxel and adjuvant therapy in people with Lung Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 15 sites in France.

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: status not confirmed, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. 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?

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?

Time to progression. 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 NCT00274898.

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 9 Feb 2009.

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