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

Sponsor
Fundacion Clinic per a la Recerca Biomédica
Study ID
NCT02316327
Phase
PHASE4
Status
Completed

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Dec 12, 2014
Start date
Jul 31, 2013
Status verified
Oct 2016
Primary completion
Sep 30, 2016
Completion
Oct 31, 2016

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: gemcitabine, cisplatin and bevacizumab
    Bevacizumab will be given by I.V infusion at the dose of 7.5 mg/kg on days 1 every 21 days Cisplatin 80 mg/m2 I.V on day 1 Gemcitabine 1250 mg/m2 I.V on day 1 \& 8 Treatment cycles will be repeated every three weeks up to 6 cycles Bevacizumab monotherapy as maintenance allowed in non-progressive tumors

Primary Outcome Measure

To evaluate blood supply, blood volume, time to peak flow increase and permeability and relation with the objective response to treatment (RC+RP) [ Time Frame: The results on baseline and day 7 to treatment in terms of blood suply, blood volume, time of peak flow increase and permeability and relation with the objective (RC+RP) at day 42. ]

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