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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753909
• Other study ID #: CT/08.17
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2008
• Last updated: October 3, 2016
• Start date: November 2008
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
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	University Hospital of Heraklion, Dep of Medical Oncology	Heraklion	Creta
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

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Toxicity profile		Toxicity assessment of each chemotherapy cycle	Yes
Secondary	Time to Tumor Progression		1-year	No
Secondary	Overall Survival		1 year	No