Paclitaxel-bevacizumab in Advanced Lung Cancer (Ultimate)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT01763671
First received: January 7, 2013
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel.

Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage.

Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile.


Condition Intervention Phase
Non Squamous Non Small Cell Lung Cancer
Drug: Docetaxel
Drug: Paclitaxel
Drug: Bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study Comparing the Efficacy of Paclitaxel-bevacizumab With Docetaxel in 2nd or 3rd Line of Treatment of Non Squamous Non Small Cells Lung Cancer

Resource links provided by NLM:


Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: about 4 months ] [ Designated as safety issue: No ]
    Time between inclusion and progression


Secondary Outcome Measures:
  • Response Rate [ Time Frame: At 8 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: about 8 months ] [ Designated as safety issue: No ]
    Time between inclusion and death


Estimated Enrollment: 164
Study Start Date: May 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Docetaxel Drug: Docetaxel
75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Experimental: Paclitaxel - Bevacizumab Drug: Paclitaxel
90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Drug: Bevacizumab
10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.

  Eligibility

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

Inclusion Criteria:

  • 2nd or 3rd line of non squamous non small cell lung cancer of stage III or IV
  • Document progression at the time of the inclusion. At least, one previous chemotherapy line with platinum. Patient who had previous treatment with bevacizumab can be included.
  • Patient with active mutation of EGFR must have had on line of chemotherapy with platinum and one with Tyrosine kinase inhibitor of EGFR.
  • Patient with ALK rearrangement must have had at least one line of chemotherapy with platinum and one with crizotinib.

Exclusion Criteria:

  • Mixed cancer small cells and non small cells or squamous lung cancer.
  • Central nervous system symptomatic metastasis or requiring immediate cerebral radiotherapy
  • patient who have had previous treatment with taxane (docetaxel, paclitaxel). Peri-operatory chemotherapy or chemoradiotherapy with taxane allowed if stopped more than 6 months before.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763671

  Show 55 Study Locations
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Investigators
Principal Investigator: Alexis CORTOT, MD CHRU Lille
Principal Investigator: Benjamin BESSE, MD Institut Gustave Roussy - Villejuif
  More Information

Additional Information:
No publications provided

Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT01763671     History of Changes
Other Study ID Numbers: IFCT-1103
Study First Received: January 7, 2013
Last Updated: August 12, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
Lung cancer
Paclitaxel bevacizumab

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

ClinicalTrials.gov processed this record on October 21, 2014