NCT02316327

Open-label Study in Patients With Metastatic NSLC Treated With Cisplatin, Gemcitabine and Bevacizumab

Phase IV/II Open-label Study to Evaluate Prompt Response to Treatment With Cisplatin, Gemcitabine and Bevacizumab in Patients With Non-small Lung Cancer.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Classically the evaluation of response in lung cancer has been based in comparing pre \& post treatment tumour volume by means of studying changes in the diameter of the selected target lesions by RECIST. The introduction of new targeted drugs creates the need of a different response assessment. Functional imaging techniques are able to study in vivo physiological processes of angiogenesis. Therefore, dynamic techniques may be more appropriate for assessing response to antiangiogenic drugs, whose mechanism of action is focused on tumor's vasculature normalization. Preliminary studies have demonstrated significant and very early changes in indirect vasculature parameters such as flow, blood volume and tumor perfusion with vascular-targeting agents. These techniques may be useful for selecting patients who are going to benefit from antiangiogenic therapy by an early evaluation of response by means of functional imaging method. PURPOSE: IMPACT is an open-label, single arm phase II/IV study to evaluate the predictive value and early radiologic response or perfusion computed tomography (CT) in patients diagnosed with unresectable advanced, metastatic or recurrent non-squamous NSCLC treated with bevacizumab in combination with chemotherapy.

Detailed description

OBJECTIVES Primary objective: • To assess early tumour response (at day +7) in terms of blood flow as compared to Objective Response Rate (ORR) in terms of RECIST criteria (CR + PR) at day 42. Secondary objectives: * To assess early tumour response (at day +7) in terms of blood volume, mean transit time, enhancement peak, time to the enhancement peak and capillary tumour permeability as compared to ORR (CR + PR) at day 42. * To assess tumour response (at day +42) in terms of blood flow, blood volume, mean transit time, enhancement peak, time to the enhancement peak and capillary tumour permeability as compared to ORR (CR + PR) at day 42. * To assess tumour response (at day +7 and +42) in terms of blood flow, blood volume, mean transit time, enhancement peak, time to the enhancement peak and capillary tumour permeability as compared to PFS and OS * Safety profile using NCI-CTC AE (version 4.0). * To assess the efficacy in the subgroup of adenocarcinoma pts. Outline: Patients receive bevacizumab 7.5mg/kg IV, cisplatin 80mg/m2 and gemcitabine 1250 mg/m2 on days 1 and 8 up to 6 cycles of 21 days. Patients without progression may continue maintenance treatment with single-agent bevacizumab 7.5 mg/Kg on day 1 every 21 days.

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	gemcitabine, cisplatin and bevacizumab	Therapeutic

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2014-12-12
• Last updated: 2016-10-05

Locations

1 site across 1 country: Spain