Pemetrexed Plus Bevacizumab in Non Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: Pemetrexed; Drug: Bevacizumab

• Registration Number: NCT00741221
• Lead Sponsor: Hellenic Oncology Research Group

Brief Summary

This trial will evaluate the efficacy and safety of pemetrexed and bevacizumab combination in patients with pretreated, advanced non small cell lung cancer (NSCLC).

Detailed Description

Pemetrexed is and an effective and well tolerated cytotoxic agent in the 2nd line treatment of advanced or metastatic non small cell lung cancer (NSCLC). Recently, a phase III study of 1st line treatment in patients with advanced or metastatic NSCLC showed that the addition of bevacizumab to a platinum-based regimen provided a survival benefit. There are patients with NSCLC who have not received bevacizumab and have relapsed after 1st and/or 2nd line therapy. The evaluation of bevacizumab plus chemotherapy in such patients is justified. This study will evaluate the combination of pemetrexed and bevacizumab as 2nd or 3rd line treatment of NSCLC.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Histologically or cytologically confirmed,
• Unresectable locally advanced (stage IIIB) or metastatic (stage IV) non-squamous NSCLC
• At least one and no more than two previous chemotherapy regimens for advanced - or metastatic NSCLC
• Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm.
• Age ≥ 18 years.
• Performance status (WHO) 0-2.
• Life expectancy of at least 12 weeks.
• Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 Upper normal limit, SGOT/SGPT ≤ 2.5 Upper normal limit in the absence of liver metastases or ≤ 5 Upper normal limit in the presence of liver metastases), and renal function (Creatinine ≤ 1,5 Upper normal limit).
• Patients must be able to understand the nature of this study and give written informed consent

Exclusion Criteria

• Previous therapy with pemetrexed
• Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
• Pregnant or lactating women
• Any serious, uncontrolled comorbidity on the investigator's judgment. Uncontrolled infection
• Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)
• Symptomatic neuropathy > grade 2 according to the NCI CTCAE (version 3.0)
• Brain metastases, except if radiated and asymptomatic
• Radiotherapy within the previous 4 weeks
• Previous radiotherapy to the only measurable lesion
• Proteinuria ≥ 500 mgr of protein daily
• Hemoptysis > 10 cc per event
• Clinically significant hematemesis
• Centrally located lesion or in contact with major vessels
• Pulmonary lesion with cavitation
• Documented hemorrhagic diathesis or coagulation disorder
• Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular arrhythmia, uncontrolled hypertension)
• Thrombotic event within the previous 6 months
• Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
• Concurrent treatment with other anti-cancer drug
• Major surgical procedure within the previous 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Pemetrexed	Pemetrexed/Bevacizumab
1	Bevacizumab	Pemetrexed/Bevacizumab

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	1 year

Secondary Outcome Measures

Name	Time	Method
Overall Survival	1 year
Overall response rate	Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Quality of life assessment	Assessment every two cycles
Toxicity profile	Assessment every two cycles

Trial Locations

Locations (10)

Air Forces Military Hospital, Dep of Medical Oncology; 🇬🇷 Athens, Greece

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases; 🇬🇷 Athens, Greece

401 Military Hospital, Medical Oncology Unit; 🇬🇷 Athens, Greece

Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases; 🇬🇷 Athens, Greece

Theagenion" Anticancer Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece

University Hospital of Heraklion; 🇬🇷 Heraklion, Crete, Greece

"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine; 🇬🇷 Athens, Greece

IASO" General Hospital of Athens, 1st Dep of Medical Oncology; 🇬🇷 Athens, Greece