NCT00522886

Brief Summary

To determine the MTD toxicity of standard dose cetuximab together with concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

July 19, 2011

Status Verified

July 1, 2011

Enrollment Period

4.3 years

First QC Date

August 29, 2007

Last Update Submit

July 18, 2011

Conditions

Non-small Cell Lung Cancer

Keywords

cetuximabconcurrentiso-toxicNSCLC

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) 3 months after the ende of chemo-radiation

    3 months

Secondary Outcomes (1)

  • During and after chemo-radiation: (CTC 3.0) Dysphagia, Cough, Dyspnea, Skin rash, Myelitis, Neuropathy, Neutrophiles, Platelets, Hemoglobin, Diarrhea, Renal failure, Liver dysfunction, Tumour response 3 m. after end chemo-radiation and Survival

    3 months

Interventions

CetuximabDRUG

Eligible patients will be given 2 cycles(of 21 days) of carboplatin (AUC 5) day 1 and gemcitabine (1250 mg/m2) days 1,8. Patients without progressive disease will be entered in the phase I dose-escalation part of the study. Chest radiation will be given concurrently with cetuximab, cisplatin and vinorelbine, which will be escalated in 3 steps until dose-limiting toxicity occurs. 14 days after the last gemcitabine (=day 43), radiotherapy is started : First 3 weeks: 1.5 Gy BID to a dose of 45 Gy in 30 fractions, then 2 Gy QD to a mean lung dose of 19 Gy. Cetuximab: 400 mg/m2 7 days before radiotherapy (= day 36) and during the course of radiotherapy a weekly dose 250 mg/m2. Cetuximab will be delivered at the same days as chemotherapy. Cisplatin(all steps): 50 mg/m2 days 43, 50; 40 mg/m2 day 64. Vinorelbine: Step 1: 10 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. Step 2: 20 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. Step 3: 20 mg/ m2 days 43, 50; 15 mg/m2 days 66 and 73.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed non-small cell lung cancer
  • Inoperable stage III (UICC 2002; sixth edition) (no pleural effusion)
  • WHO performance status 0 or 1
  • Less than 10% weight loss in the last 6 months
  • Lung function: FEV1 at least 50% and DLCO at least 50% of the predicted value
  • No recent severe cardiac disease
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate hepatic function
  • Life expectancy more than 6 months
  • Measurable cancer
  • Willing and able to comply with study prescriptions
  • years or older
  • Not pregnant or breast feeding
  • Written informed consent
  • +1 more criteria

You may not qualify if:

  • Not non-small cell lung cancer histology
  • Mixed pathology
  • History of prior chest radiotherapy
  • Recent (\<3 months) myocardial infarction
  • Uncontrolled infectious disease
  • Less than 18 years old
  • Inadequate pulmonary function
  • Other active malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht Radiation Oncology, MAASTRO clinic

Maastricht, Limburg, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Dirk De Ruysscher, MD PhD

    Maastro Clinic, The Netherlands

    PRINCIPAL INVESTIGATOR

  • Anne-Marie Dingemans, MD PhD

    academisch ziekenhuis Maastricht, azM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 30, 2007

Study Start

April 1, 2007

Primary Completion

July 1, 2011

Last Updated

July 19, 2011

Record last verified: 2011-07

Locations

NL(1)