Bevacizumab Versus Docetaxel/Erlotinib on Tumor Metrics in Patients With Previously Untreated Advanced Non Small Cell Lung Cancer

Impact of Bevacizumab Versus Docetaxel/Erlotinib on Tumor Metrics in Patients With Previously Untreated Advanced Non Small Cell Lung Cancer: A Study by the Hellenic Co-operative Oncology Group

To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer

Detailed Description

In 2008, the Hellenic Co-operative Oncology group (HeCOG) initiated a randomized phase II study to determine the comparative efficacy of intermittent docetaxel/erlotinib chemotherapy, with erlotinib given for twelve consecutive days either before (group A) or after (group B) docetaxel, in chemotherapy-naive patients with advanced non small cell lung cancer. Docetaxel chemotherapy was considered one of the valid non-platinum containing therapeutic options at that time and today represents one of the approved second-line treatment options after failure of first-line platinum based chemotherapy. The trial was terminated early due to slow accrual after enrollment of 51 patients and was published in 2014, showing no clinically meaningful difference between the two treatment arms.

Based on the aforementioned trial population,a parallel radiological study was conducted, evaluating sequential tumor metrics on computed tomography performed at baseline and after each cycle of treatment in patients receiving either bevacizumab or docetaxel/erlotinib. Given the differential mechanism of action of these agents, it was hypothesized that the different parameters of radiological tumor response evaluation, namely the maximum diameter, tumor volume and tumor density, would respond differently for each therapeutic category (a chemotherapeutic agent, a molecular agent and and an anti-angiogenic agent). For bevacizumab, in particular, it was hypothesized that its unique mechanism of action, inducing central tumor necrosis and subsequent shrinkage, would lead to completely different tumor metrics as compared to the other two agents. Herein the final results of this analysis are presented, showing the comparison of the three agents in terms of tumor response metrics, as evaluated in CT scans performed at baseline and after each cycle of treatment

• Study Type: Observational
• Enrollment (Actual): 58

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with non small cell lung cancer evaluated with Computed Scan or Magnetic Resonance Imaging.

Description

Inclusion Criteria:

1. Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic non small cell lung cancer will be enrolled.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
3. Presence of measurable or evaluable disease (lesions that are present but do not fulfil the criteria for measurable disease).

Exclusion Criteria:

1. Patients who have undergone complete tumor resection after responding to platinum based chemotherapy.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Erlotinib followed by docetaxel; Erlotinib given for twelve consecutive days before docetaxel
Docetaxel followed by erlotinib; Erlotinib given for twelve consecutive days after docetaxel
Bevacizumab treated; Bevacizumab treated patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response	Evaluation of response using RECIST 1.1 criteria (REF) was based on the measurement of a total of 5 measurable lesions.	Every 12 -16 weeks

Collaborators and Investigators

• Sponsor: Hellenic Cooperative Oncology Group

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: Neo-Doperlo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No