NCT00613626

Cisplatin + Etoposide +/- Concurrent ZD6474 in Previously Untreated Extensive Stage Small Cell Lung Cancer

A Randomized Double Blind Phase II Trial of Cisplatin Plus Etoposide With/Without Concurrent ZD6474 in Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer: Hoosier Oncology Group LUN06-113

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

At this point in the treatment of extensive stage SCLC, we have reached a plateau in survival with conventional chemotherapy and newer regimens are greatly needed. It has been noted that patients with increased VEGF levels have a poorer prognosis. Anti-angiogenic agents hold significant promise in the treatment of patients with extensive stage SCLC. ZD6474, a new inhibitor of the VEGFR-2, has shown favorable action in NSCLC.

Detailed description

OUTLINE: This is a multi-center study. Arm A: Cisplatin 60mg/m2 Day 1 + Etoposide 120mg/m2 Day 1,2,3 + Placebo oral daily given continuously for the duration of the study Arm B: Cisplatin 60mg/m2 Day 1 + Etoposide 120mg/m2 Day 1,2,3 + ZD6474 100mg oral daily given continuously for the duration of the study For both arms, PE and toxicity evaluation prior to each cycle and disease assessment by imaging every 2 cycles. Patients with non-PD and acceptable toxicity will continue protocol therapy; patients with progressive disease or excessive toxicity will be taken off treatment. Cycles will be repeated every 21 days up to a total of 4 cycles. ECOG Performance Status of 0 or 1 Life Expectancy: Not specified Hematopoietic: * Platelets \> 100K/mm3 * Absolute neutrophil count (ANC) \> 1.5K/mm3 Hepatic: * Bilirubin \< 1.5 x ULN * Aspartate aminotransferase (AST) \< 2.5 x ULN or \< 5 x ULN if judged by the investigator to be related to liver metastases * Alkaline phosphatase \< 2.5 x ULN or \< 5 x ULN if judged by the investigator to be related to liver metastases Renal: * Serum creatinine \< 1.5 x ULN or Calculated creatinine clearance of \> 45 cc/min using the Cockcroft-Gault formula Cardiovascular: * No clinically significant cardiac event such as myocardial infarction; New York Heart Association (NYHA) classification of heart disease \>2 (see SPM) within 3 months prior to registration for protocol therapy * No presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia. * No history of arrhythmia (multifocal premature ventricular contractions (PVCs), bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is permitted.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
DRUG	Etoposide	Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
DRUG	Placebo	Matched placebo oral daily
DRUG	ZD6474	ZD6474 100mg oral daily to be continued for the duration of the study.

Timeline

• Start date: 2008-01-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2008-02-13
• Last updated: 2020-02-11
• Results posted: 2015-11-18

Locations

19 sites across 1 country: United States