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

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Sanofi
TAKO - Tiroler Arbeitskreis Onkologie
Information provided by (Responsible Party):
Wolfgang Hilbe, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00406302
First received: December 1, 2006
Last updated: April 28, 2014
Last verified: April 2014

December 1, 2006
April 28, 2014
January 2007
June 2011   (final data collection date for primary outcome measure)
overall response rate (complete plus partial response) according to RECIST guidelines [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00406302 on ClinicalTrials.gov Archive Site
  • Pathological response [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
  • Metabolic response [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
  • Immunological response [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
  • Safety profile and tolerability [ Time Frame: June 2011 ] [ Designated as safety issue: Yes ]
  • overall response rate (complete plus partial response) according to RECIST guidelines [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Immune Response on Neoadjuvant Therapy in Non-small-cell Lung Cancer (NSCLC)
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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-small-cell Lung
  • Drug: Docetaxel
    75mg/m², day 1,22
    Other Name: Taxotere
  • Drug: oxaliplatin
    40mg/m², d1,2,22,23
    Other Name: CDDP
  • Drug: cetuximab
    400mg/m² (day1), 250mg/m² (day 8,15,22,29,36)
    Other Name: Erbitux
  • Procedure: surgery
    28 days after end of induction chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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.
  • 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.

Exclusion Criteria:

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
  • 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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00406302
2006-004639-31
No
Wolfgang Hilbe, Medical University of Vienna
Wolfgang Hilbe
  • Merck Sharp & Dohme Corp.
  • Sanofi
  • TAKO - Tiroler Arbeitskreis Onkologie
Principal Investigator: Wolfgang Hilbe, Prof. Dr. University Hospital Innsbruck, Internal Medicine
Medical University of Vienna
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP