Status: Closed
Activation Date: 2003MAY12
Closing Date: 2006MAR13
Phase: II
Description: A Phase II Study of ZD6474 or Placebo in Small Cell Lung Cancer Patients Who Have Complete or Partial Response to Induction Chemotherapy Plus Radiation Therapy
Eligibility: Patients must have histological or cytological proof of small cell carcinoma of the lung. Patients must have achieved a complete or partial response after chemotherapy +/- radiotherapy. Patients must have received a minimum of 4 cycles of the first line combination chemotherapy within 28 days of randomization. Radiology must be performed within 28 days of randomization and must show continued CR or PR. Patients must have a current performance status of ECOG 0, 1 or 2. Patient must have a life expectancy of at least 12 weeks and be 16 years of age or older.aen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test. Patient is able and willing to complete the quality of life questionnaires in either English or French. Patients registered on this trial must be treated and followed at the participating centres.
Objective: To compare progression-free survival (PFS) for small cell lung cancer (SCLC) patients who have received either ZD6474 or placebo. To compare the response rate (for patients with measurable disease outside the radiation field at entry) for SCLC patients who have received either ZD6474 or placebo. To compare toxicity and tolerability for SCLC patients who have received either ZD6474 or placebo. To assess pharmacokinetics for SCLC patient who received either ZD6474 or placebo: To compare QoL for SCLC patients who have received either ZD6474 or placebo. To confirm the prognostic significance of VEGFR (? p-VEGFR) expression and microvessel density in tumour with outcomes and response to treatment for consenting patients who had a histological specimen at diagnosis (section 18). To provide a comprehensive tumour, plasma and urine bank (section 17 and 18) linked to a clinical database for the further study of molecular markers in SCLC.
Participation: Limited to 20 NCIC CTG centres.
Lay Description: This trial is for patients who have small cell cancer of the lung. The trial objective is to find out whether it is better to receive a new drug ZD6474 or better to receive no further treatment after you have completed your chemotherapy (with or without radiation).
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| LUNG | BR20 | 107 | 53 | 7 | 55 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| LUNG | BR20 | 107 | 1 | 1 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| LUNG | BR20 | 107 | 0 | 0 | 0 | 1 | 99 | 0 | 93 | 0 |