Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer

NCT ID: NCT00753909

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2016-10-31

Brief Summary

This trial will evaluate the efficacy and safety of paclitaxel, carboplatin and bevacizumab combination, administered biweekly, in patients with pretreated, advanced non small cell lung cancer.

Detailed Description

The addition of bevacizumab to paclitaxel plus carboplatin in the 1st line treatment of patients with advanced or metastatic non small cell lung cancer (NSCLC) 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. The combination of paclitaxel and carboplatin, administered every two weeks, has a favorable toxicity profile. This study will evaluate the addition of bevacizumab to a biweekly regimen of paclitaxel and carboplatin as 2nd or 3rd line therapy for NSCLC

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Paclitaxel/Carboplatin/Bevacizumab

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

Carboplatin (IV) 3 AUC on day 1 and day 15 every 4 weeks for 6 cycles

Bevacizumab

Intervention Type: DRUG

Bevacizumab (IV) 10 mg/kg on day 1 and day 15 every 4 weeks for 6 cycles Followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression

Paclitaxel

Intervention Type: DRUG

Paclitaxel (IV) 140 mg/m2,on day 1 and day 15 every 4 weeks for 6 cycles

Interventions

Carboplatin

Carboplatin (IV) 3 AUC on day 1 and day 15 every 4 weeks for 6 cycles

Intervention Type: DRUG

Bevacizumab

Bevacizumab (IV) 10 mg/kg on day 1 and day 15 every 4 weeks for 6 cycles Followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression

Intervention Type: DRUG

Paclitaxel

Paclitaxel (IV) 140 mg/m2,on day 1 and day 15 every 4 weeks for 6 cycles

Intervention Type: DRUG

Other Intervention Names

Avastin; Taxoprol; Paxene; Taxol

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB) or metastatic (stage IV) non-squamous NSCLC
• Non-squamous histologic type
• 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 ≥ 9 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
• Written informed consent

Exclusion Criteria

• Previous therapy with paclitaxel in combination with carboplatin
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sofia Agelaki, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete

Locations

University Hospital of Heraklion, Dep of Medical Oncology

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis

Alexandroupoli, , Greece

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

Athens, , Greece

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

Athens, , Greece

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

Athens, , Greece

401 Military Hospital of Athens

Athens, , Greece

Air Forces Military Hospital of Athens

Athens, , Greece

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, , Greece

"Diabalkaniko" hospital, Thessaloniki

Thessaloniki, , Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

CT/08.17

Identifier Type: -

Identifier Source: org_study_id