Pemetrexed Plus Bevacizumab in Non Small Cell Lung Cancer

Hellenic Oncology Research Group

Status and phase

Completed

Phase 2

Conditions

Non-small-cell Lung Cancer

Treatments

Drug: Bevacizumab

Drug: Pemetrexed

Study type

Interventional

Funder types

Other

Identifiers

NCT00741221

CT/08.10

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No 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