Docetaxel and oxaliplatin and cetuximab in Carcinoma, Non-small-cell Lung - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Carcinoma, Non-small-cell Lung

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Linz, Austria, A-4010
    - Prim. Dr. Bolitschek
  - Linz, Austria, A-4020
    - Prim. Dr. H. Schinko
  - Wels, Austria, A-4600
    - OA Dr. Rainer Kolb
- Tirol
  - Innsbruck, Tirol, Austria, A-6020
    - University Hospital, Internal Medicine
  - Kufstein, Tirol, Austria, A-6330
    - Hosptial Kufstein
  - Natters, Tirol, Austria, A-6161
    - Hospital Natters
  - Zams, Tirol, Austria, A-6511
    - Hospital Zams

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall response rate (complete plus partial response) according to RECIST guidelines Time Frame: June 2011	June 2011

Secondary Outcome Measures

Outcome Measure	Time Frame
overall response rate (complete plus partial response) according to RECIST guidelines Time Frame: June 2011	June 2011
Pathological response Time Frame: June 2011	June 2011
Metabolic response Time Frame: June 2011	June 2011
Immunological response Time Frame: June 2011	June 2011
Overall survival Time Frame: June 2011	June 2011
Safety profile and tolerability Time Frame: June 2011	June 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfgang Hilbe

Collaborators

Sanofi

Merck Sharp & Dohme LLC

TAKO - Tiroler Arbeitskreis Onkologie

Investigators

Principal Investigator: Wolfgang Hilbe, Prof. Dr., University Hospital Innsbruck, Internal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.
Rosell R., et al. Proc Am Soc Clin Oncol 23: 618, 2004
Betticher DC, et al. Proc Am Soc Clin Oncol: 1824, 1999

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 1, 2006

First Submitted That Met QC Criteria