Paclitaxel-bevacizumab in Advanced Lung Cancer (Ultimate)

• ClinicalTrials.gov Identifier: NCT01763671
• Recruitment Status: Completed
• First Posted: January 9, 2013
• Last Update Posted: March 14, 2023
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique
• Information provided by (Responsible Party): Intergroupe Francophone de Cancerologie Thoracique

Tracking Information

• First Submitted Date: January 7, 2013
• First Posted Date: January 9, 2013
• Last Update Posted Date: March 14, 2023
• Study Start Date: May 2013
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 8, 2013)

Progression free survival [ Time Frame: about 4 months ]

Time between inclusion and progression

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 8, 2013)

• Response Rate [ Time Frame: At 8 weeks ]
• Overall survival [ Time Frame: about 8 months ]
  Time between inclusion and death

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Paclitaxel-bevacizumab in Advanced Lung Cancer
• 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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-squamous Non-small Cell Lung Cancer

Intervention

• Drug: Docetaxel
  75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
• 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.

Study Arms

• Active Comparator: Docetaxel
  Intervention: Drug: Docetaxel
• Experimental: Paclitaxel - Bevacizumab
  Interventions:

  • Drug: Paclitaxel
  • Drug: Bevacizumab

• Publications *: Cortot AB, Audigier-Valette C, Molinier O, Le Moulec S, Barlesi F, Zalcman G, Dumont P, Pouessel D, Poulet C, Fontaine-Delaruelle C, Hiret S, Dixmier A, Renault PA, Becht C, Raffy O, Dayen C, Mazieres J, Pichon E, Langlais A, Morin F, Moro-Sibilot D, Besse B. Weekly paclitaxel plus bevacizumab versus docetaxel as second- or third-line treatment in advanced non-squamous non-small-cell lung cancer: Results of the IFCT-1103 ULTIMATE study. Eur J Cancer. 2020 May;131:27-36. doi: 10.1016/j.ejca.2020.02.022. Epub 2020 Apr 8.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 10, 2023): 166
• Original Estimated Enrollment (submitted: January 8, 2013): 164
• Actual Study Completion Date: April 2017
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01763671
• Other Study ID Numbers: IFCT-1103
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
• Original Responsible Party: Same as current
• Current Study Sponsor: Intergroupe Francophone de Cancerologie Thoracique
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Alexis CORTOT, MD; CHRU Lille
• Principal Investigator: Benjamin BESSE, MD; Gustave Roussy, Cancer Campus, Grand Paris

• PRS Account: Intergroupe Francophone de Cancerologie Thoracique
• Verification Date: March 2023