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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

Phase 2
18 Years
80 Years
Open (Enrolling)
Carcinoma, Non-small-cell Lung

Thank you

Trial Information

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.

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.

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,

- 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

- 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:


- Evidence of brain metastases or other distant metastasis equivalent to stage IV

- 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

- History of significant neurological or psychiatric disorders, including dementia or

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

June 2011

Safety Issue:


Principal Investigator

Wolfgang Hilbe, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Innsbruck, Internal Medicine


Austria: Agency for Health and Food Safety

Study ID:




Start Date:

January 2007

Completion Date:

June 2011

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • non-small-cell lung cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms