Phase I study of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with limited-disease small cell lung cancer

Completed

• Conditions: imited-Disease Small Cell Lung Cancer (LD-SCLC); Cancer; Lung Cancer

• Registration Number: ISRCTN75771514
• Lead Sponsor: Erasmus Medical Centre (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

1. Cytologically or histologically proven SCLC
2. Disease confined to one hemithorax without evidence of cytologically proven malignant pleural effusion
3. No prior chemotherapy and/or radiotherapy
4. Age 18 years or older
5. Performance score zero or one
6. Adequate organ functions:
a. White Blood Cells (WBC) greater than 3.0 x 10^9/L
b. Absolute Neutrophil Count (ANC) greater than 1.5 x 10^9/L
c. platelets greater than 100 x 10^9/L
d. serum creatinine less than 135 mmol/L or creatinine clearance according to Cockroft-Gault formula greater than 60 ml/min
e. bilirubin less than 1.25 Upper Limit of Normal (ULN)
f. Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) less than 2.5 ULN
g. Lactate Dehydrogenase (LDH) less than 1.25 ULN
7. Adequate pulmonary function (Forced Expiratory Volume in one second [FEV1] greater than 30% of predicted, Diffusing capacity of the Lung for Carbon Monoxide [DLCO] greater than 40% of predicted)
8. No prior malignancy unless five years in complete remission except for patients with prior breast cancer or melanoma. Patients with adequately treated basocellular carcinoma of the skin or cervical cancer are eligible
9. Written informed consent

Exclusion Criteria

1. Other serious illnesses
2. Concurrent therapy with other anti-cancer drugs
3. Pregnancy or lactation
4. Presence of diarrhoea
5. Presence of suspicion of bowel obstruction or chronic inflammatory bowel disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified