Clinical trial NCT00753909: Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer
Official title: Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
Paclitaxel
Carboplatin
Bevacizumab
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
First posted: 2008-09-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Overall Response Rate
timeFrame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes:
measure: Toxicity profile
timeFrame: Toxicity assessment of each chemotherapy cycle
measure: Time to Tumor Progression
timeFrame: 1-year
measure: Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Heraklion, Dep of Medical Oncology
state: Creta
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis
city: Athens
country: Greece
facility: "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
city: Athens
country: Greece
facility: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
city: Athens
country: Greece
facility: "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
city: Athens
country: Greece
facility: 401 Military Hospital of Athens
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Larissa
country: Greece
facility: State General Hospital of Larissa, Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: "Diabalkaniko" hospital, Thessaloniki
city: Thessaloniki
country: Greece
facility: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Study officials:
affiliation: University Hospital of Crete
name: Sofia Agelaki, MD
role: PRINCIPAL_INVESTIGATOR
References: