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

NCT00753909 | Completed Phase 2

• 1 other identifier: CT/08.17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 10

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; Paclitaxel; Carboplatin; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcomes (3)

• Toxicity profile

  Toxicity assessment of each chemotherapy cycle

• Time to Tumor Progression

  1-year

• Overall Survival

  1 year

Study Arms (1)

1

EXPERIMENTAL

Paclitaxel/Carboplatin/Bevacizumab

Drug: Carboplatin; Drug: Bevacizumab; Drug: Paclitaxel

Interventions

Carboplatin DRUG

Carboplatin (IV) 3 AUC on day 1 and day 15 every 4 weeks for 6 cycles

1

Bevacizumab DRUG

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

Also known as: Avastin

1

Paclitaxel DRUG

Paclitaxel (IV) 140 mg/m2,on day 1 and day 15 every 4 weeks for 6 cycles

Also known as: Taxoprol, Paxene, Taxol

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead

Study Sites (10)

University Hospital of Heraklion, Dep of Medical Oncology

Heraklion, Crete, Greece

Location

University General Hospital of Alexandroupolis

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

Location

"Diabalkaniko" hospital, Thessaloniki

Thessaloniki, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Bevacizumab; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Sofia Agelaki, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 17, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

GR (10)