Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00753909

Purpose

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.

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: Carboplatin Drug: Bevacizumab Drug: Paclitaxel	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity profile [ Time Frame: Toxicity assessment of each chemotherapy cycle ] [ Designated as safety issue: Yes ]
Time to Tumor Progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Paclitaxel/Carboplatin/Bevacizumab	Drug: Carboplatin Carboplatin (IV) 3 AUC on day 1 and day 15 every 4 weeks for 6 cycles 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 Drug: Paclitaxel Paclitaxel (IV) 140 mg/m2,on day 1 and day 15 every 4 weeks for 6 cycles

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753909

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Eva Maragkoudaki	+302810392857	dorachat@med.uoc.gr

Locations

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
"IASO" General Hospital of Athens, 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
University General Hospital of Alexandroupolis
Alexandroupolis, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
"Diabalkaniko" hospital, Thessaloniki
Thessaloniki, Greece
Greece, Creta
University Hospital of Heraklion, Dep of Medical Oncology
Heraklion, Creta, Greece

Sponsors and Collaborators

Hellenic Oncology Research Group

University Hospital of Crete

Investigators

Principal Investigator:

Sofia Agelaki, MD

University Hospital of Crete

More Information

Responsible Party:	University Hospital of Crete ( S.Agelaki )
Study ID Numbers:	CT/08.17
Study First Received:	September 16, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00753909
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Non Small Cell Lung Cancer
Paclitaxel
Carboplatin
Bevacizumab

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases

Carboplatin
Bevacizumab
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009