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

Information source: Hellenic Oncology Research Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Small Cell Lung Cancer

Intervention: Carboplatin (Drug); Bevacizumab (Drug); Paclitaxel (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Hellenic Oncology Research Group

Official(s) and/or principal investigator(s):
Sofia Agelaki, MD, Principal Investigator, Affiliation: University Hospital of Crete

Overall contact:
Dora Hatzidaki, Phone: +302810392570, Email: dorachat@med.uoc.gr

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Response Rate

Secondary outcome:

Toxicity profile

Time to Tumor Progression

Overall Survival

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Dora Hatzidaki, Phone: +302810392570, Email: dorachat@med.uoc.gr

University General Hospital of Alexandroupolis, Alexandroupolis, Greece; Recruiting
Dora Hatzidaki, Phone: +302810392570, Email: dorachat@med.uoc.gr
Eva Maragkoudaki, Phone: +302810392857, Email: dorachat@med.uoc.gr
Stelios Kakolyris, MD, Principal Investigator

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, Greece; Recruiting
Nikoleta Karkatzou, MD, Phone: +302106448666, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Stelios Giassas, MD, Principal Investigator

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece; Recruiting
Nikoleta Karkatzou, MD, Phone: +302106448666, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302810392857, Email: secretary@horg.gr
Aris Polyzos, MD, Principal Investigator

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology, Athens, Greece; Recruiting
Nikoleta Karkatzou, MD, Phone: +302106448666, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302810392857, Email: secretary@horg.gr
Nikos Ziras, MD, Principal Investigator

401 Military Hospital of Athens, Athens, Greece; Recruiting
Nikoleta Karkatzou, MD, Phone: +302106448666, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Charalampos Christophillakis, MD, Principal Investigator

Air Forces Military Hospital of Athens, Athens, Greece; Recruiting
Nikoleta Karkatzou, MD, Phone: +302106448666, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +30281392857, Email: secretary@horg.gr
Nikos Kentepozidis, MD, Principal Investigator

State General Hospital of Larissa, Dep of Medical Oncology, Larissa, Greece; Recruiting
Nikoleta Karkatzou, MD, Phone: +302106448666, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Athanasios Athanasiadis, MD, Principal Investigator

"Diabalkaniko" hospital, Thessaloniki, Thessaloniki, Greece; Recruiting
Nikoleta Karkatzou, MD, Phone: +302106448666, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Christos Emmanouilidis, MD, Principal Investigator

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology, Thessaloniki, Greece; Recruiting
Nikoleta Karkatzou, MD, Phone: +302106448666, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Ioannis Boukovinas, MD, Principal Investigator

University Hospital of Heraklion, Dep of Medical Oncology, Heraklion, Creta, Greece; Recruiting
Dora Hatzidaki, Phone: +302810392570, Email: dorachat@med.uoc.gr
Eva Maragkoudaki, Phone: +302810392857, Email: dorachat@med.uoc.gr
Manolis Kontopodis, MD, Sub-Investigator

Additional Information

Starting date: November 2008
Last updated: June 21, 2014

Page last updated: August 20, 2015

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