Phase I Cetuximab and Concurrent Radio-chemotherapy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht Radiation Oncology
• Collaborators: Academisch Ziekenhuis Maastricht; Merck Sharp & Dohme Corp.
• Treatments: Cetuximab; Cisplatin; Vinorelbine

Criteria

Inclusion Criteria:

• 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

• 18 years or older

• Not pregnant or breast feeding

• Written informed consent

• No previous radiotherapy to the chest

Exclusion Criteria:

• 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