Back to results

Pemetrexed Plus Bevacizumab in Non Small Cell Lung Cancer

Primary Purpose

Non-small-cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Pemetrexed

Bevacizumab

About this trial

This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring Cancer, NSCLC, Docetaxel, Bevacizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital of Heraklion
University General Hospital of Alexandroupolis, Dep of Medical Oncology
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
401 Military Hospital, Medical Oncology Unit
Air Forces Military Hospital, Dep of Medical Oncology
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Theagenion" Anticancer Hospital of Thessaloniki

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Pemetrexed/Bevacizumab

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Overall response rate

Overall Survival

Quality of life assessment

Toxicity profile

Full Information

NCT ID

NCT00741221

First Posted

August 25, 2008

Last Updated

October 3, 2016

Sponsor

Hellenic Oncology Research Group

1. Study Identification

Unique Protocol Identification Number

NCT00741221

Brief Title

Pemetrexed Plus Bevacizumab in Non Small Cell Lung Cancer

Official Title

Pemetrexed Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hellenic Oncology Research Group

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small-cell Lung Cancer

Keywords

Cancer, NSCLC, Docetaxel, Bevacizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Pemetrexed/Bevacizumab

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta

Intervention Description

Pemetrexed (IV) 500 mg/m2 on day 1 every 3 weeks for 6 cycles

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles After the end of the 6 cycles Bevacizumab will be administered alone at the dose of 15 mgr/Kgr (IV) every 3 weeks until disease progression

Primary Outcome Measure Information:

Title

Progression Free Survival

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall response rate

Time Frame

Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Title

Overall Survival

Time Frame

1 year

Title

Quality of life assessment

Time Frame

Assessment every two cycles

Title

Toxicity profile

Time Frame

Assessment every two cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sofia Agelaki, MD

Organizational Affiliation

University Hospital of Crete, Dep of Medical Oncology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Manolis Kontopodis, MD

Organizational Affiliation

University Hospital of Crete

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Heraklion

City

Heraklion

State/Province

Crete

Country

Greece

Facility Name

University General Hospital of Alexandroupolis, Dep of Medical Oncology

City

Alexandroupolis

Country

Greece

Facility Name

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

City

Athens

Country

Greece

Facility Name

401 Military Hospital, Medical Oncology Unit

City

Athens

Country

Greece

Facility Name

Air Forces Military Hospital, Dep of Medical Oncology

City

Athens

Country

Greece

Facility Name

IASO" General Hospital of Athens, 1st Dep of Medical Oncology

City

Athens

Country

Greece

Facility Name

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

City

Athens

Country

Greece

Facility Name

Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases

City

Athens

Country

Greece

Facility Name

"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology

City

Piraeus

Country

Greece

Facility Name

Theagenion" Anticancer Hospital of Thessaloniki

City

Thessaloniki

Country

Greece

12. IPD Sharing Statement

Learn more about this trial

Pemetrexed Plus Bevacizumab in Non Small Cell Lung Cancer

We'll reach out to this number within 24 hrs