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

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ClinicalTrials.gov Identifier: NCT00753909
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Hellenic Oncology Research Group

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Carboplatin Drug: Bevacizumab Drug: Paclitaxel Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer
Study Start Date : November 2008
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 1
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
Other Name: Avastin

Drug: Paclitaxel
Paclitaxel (IV) 140 mg/m2,on day 1 and day 15 every 4 weeks for 6 cycles
Other Names:
  • Taxoprol
  • Paxene
  • Taxol




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]

Secondary Outcome Measures :
  1. Toxicity profile [ Time Frame: Toxicity assessment of each chemotherapy cycle ]
  2. Time to Tumor Progression [ Time Frame: 1-year ]
  3. Overall Survival [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753909


Locations
Greece
University Hospital of Heraklion, Dep of Medical Oncology
Heraklion, Creta, Greece
University General Hospital of Alexandroupolis
Alexandroupolis, 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
Sponsors and Collaborators
Hellenic Oncology Research Group
Investigators
Principal Investigator: Sofia Agelaki, MD University Hospital of Crete

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00753909     History of Changes
Other Study ID Numbers: CT/08.17
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016

Keywords provided by Hellenic Oncology Research Group:
Non Small Cell Lung Cancer
Paclitaxel
Carboplatin
Bevacizumab

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors