AzTrials
AzTrials

Carcinoma, Non-small-cell LungPhase 2NCT00406302

Immune Response on Neoadjuvant Therapy in Non-small-cell Lung Cancer (NSCLC)

A Phase 2 study testing Docetaxel, oxaliplatin and cetuximab in people with Carcinoma, Non-small-cell Lung, run by Wolfgang Hilbe at 7 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Carcinoma, Non-small-cell Lung
What is being tested?
Docetaxel, oxaliplatin and cetuximab
Type of treatment
Surgery or procedure
How many people
41 participants
Where
7 sitesAustria
Study dates
Jan 2007to Jun 2011
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histology and staging of the disease
  • Histological confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC.
  • Anatomically and functionally resectable NSCLC stage IB (T2N0) stage II (T1-2 N1, T3 N0) or stage IIIA (T3 N1) (see TAKO guidelines 2006, www.tako.or.at)
  • Measurable disease according to RECIST criteria
  • General conditions
  • 18-80 years.
Show all 14Show fewer
  • WHO 0-2; life expectancy of more than 3 months
  • Effective contraception for both male and female patients if the risk of conception exists
  • Adequate respiratory function, sufficient for necessary surgical treatment
  • Adequate hematological function (Hb > 10 g/dl, ANC > 2.0 x 10 9/L, platelets > 100 x 10 9/L).
  • Adequate renal and hepatic functions: total bilirubin within normal limits, serum creatinine within normal limits, in case of limit value the creatinine clearance should be > 60 ml/min, ASAT and ALAT < 2.5 x UNL, alkaline phosphatase < 5 x UNL.
  • Initial work-up
  • Complete initial work-up within three weeks prior to first infusion includes chest CT scan, abdominal CT-scan, brain CT scan if indicated, PET-scan, bronchoscopy and mediastinoscopy, pulmonary function. Within 7 days prior to inclusion laboratory investigations and biological work up.
  • Signed initial consent prior to protocol specific procedures.

Who cannot join

  • Diagnosis
  • Evidence of brain metastases or other distant metastasis equivalent to stage IV disease
  • History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years
  • Other serious concomitant illness or medical condition:
  • Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia
  • History of significant neurological or psychiatric disorders, including dementia or seizure
Show all 19Show fewer
  • Active infection requiring i.v. antibiotics
  • Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy
  • Current peripheral neuropathy WHO grade > 2
  • Prior or concurrent therapy
  • Prior chemotherapy or immunotherapy for NSCLC
  • Prior surgery or radiotherapy for NSCLC
  • Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy
  • Concurrent continuous treatment with systemic steroids for antiemetic use, intermittent application is allowed
  • General conditions
  • Pregnant (absence to be confirmed by ß-HCG-test) or lactating patients
  • Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements
  • Participation in other clinical trials with experimental agents or non approved medical procedures during study and within 30 days prior to study entry
  • Psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with the study protocol.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Austria7 sites

  • University Hospital, Internal Medicine

    Innsbruck, Tyrol, A-6020

  • Hosptial Kufstein

    Kufstein, Tyrol, A-6330

  • Prim. Dr. Bolitschek

    Linz, A-4010

  • Prim. Dr. H. Schinko

    Linz, A-4020

  • Hospital Natters

    Natters, Tyrol, A-6161

  • OA Dr. Rainer Kolb

    Wels, A-4600

  • Hospital Zams

    Zams, Tyrol, A-6511

Other trials in Austria

About this study

Official title: Multicenter Phase II Study Evaluating Docetaxel, CDDP, and Cetuximab as Induction Regimen Prior to Surgery in Chemo-naive Patients With NSCLC Stage IB, II and IIIA

Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the RECIST guidelines.

Read the detailed description

Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the RECIST guidelines.

Secondary objective is

  • To evaluate pathological response determined by histological work up of the surgical specimens according to TNM stages.
  • To evaluate the metabolic response determined by PET analysis.
  • To assess overall survival (OS) (median survival time and percentage of 1-year survival). OS is defined as time elapsed from the date of patient inclusion until recorded date of death.
  • To characterize and quantify toxic effects of the scheduled therapy. Safety profile and tolerability will be assessed by recording adverse events, clinically significant laboratory abnormalities, physical examination and vital signs. Toxicities will be evaluated according to the NCI-CTC Toxicity Criteria and adverse events which are not reported in NCI-CTC will be graded as mild, moderate, severe or life-threatening. All patients who received any of the scheduled therapy will be included in the overall toxicity analysis.
  • To evaluate the immunological response determined by regulatory T-cells and immune activation markers, to define chemoresistance by pharmacogenomic testing.
Being tested
Docetaxel, oxaliplatin, cetuximab, surgery
Keywords
NSCLC, non-small-cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • DocetaxelDrug

    Also called Taxotere

    75mg/m², day 1,22

  • oxaliplatinDrug

    Also called CDDP

    40mg/m², d1,2,22,23

  • cetuximabDrug

    Also called Erbitux

    400mg/m² (day1), 250mg/m² (day 8,15,22,29,36)

  • surgeryProcedure or surgery

    28 days after end of induction chemotherapy

What is being measured

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

  1. overall response rate (complete plus partial response) according to RECIST guidelines

    Measured: June 2011

Secondary outcomes (6)

  1. Pathological response

    Measured: June 2011

  2. Metabolic response

    Measured: June 2011

  3. Immunological response

    Measured: June 2011

  4. Overall survival

    Measured: June 2011

  5. Safety profile and tolerability

    Measured: June 2011

  6. overall response rate (complete plus partial response) according to RECIST guidelines

    Measured: June 2011

Timeline

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

  1. First posted4 Dec 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionJun 2011
  4. Study completionJun 2011

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00406302
Sponsor's protocol ID
2006-004639-31
Status last verified
Apr 2014
First submitted
1 Dec 2006
Last updated
29 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • Fossella F, Pereira JR, von Pawel J, Pluzanska A, Gorbounova V, Kaukel E, Mattson KV, Ramlau R, Szczesna A, Fidias P, Millward M, Belani CP. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol. 2003 Aug 15;21(16):3016-24. doi: 10.1200/JCO.2003.12.046. Epub 2003 Jul 1.

    PubMed 12837811

  • Rosell R., et al. Proc Am Soc Clin Oncol 23: 618, 2004

  • Betticher DC, et al. Proc Am Soc Clin Oncol: 1824, 1999

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, oxaliplatin and cetuximab in people with Carcinoma, Non-small-cell Lung, run by Wolfgang Hilbe at 7 sites in Austria.

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

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. 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: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

overall response rate (complete plus partial response) according to RECIST guidelines (time frame: June 2011). 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 NCT00406302, which also lists 3 linked publications.

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 29 Apr 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in