Paclitaxel-bevacizumab in Advanced Lung Cancer (Ultimate)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01763671 |
|
Recruitment Status :
Completed
First Posted : January 9, 2013
Last Update Posted : March 14, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-squamous Non-small Cell Lung Cancer | Drug: Docetaxel Drug: Paclitaxel Drug: Bevacizumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 166 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (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 |
| Study Start Date : | May 2013 |
| Actual Primary Completion Date : | December 2015 |
| Actual Study Completion Date : | April 2017 |
| Arm | Intervention/treatment |
|---|---|
| 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. |
- Progression free survival [ Time Frame: about 4 months ]Time between inclusion and progression
- Response Rate [ Time Frame: At 8 weeks ]
- Overall survival [ Time Frame: about 8 months ]Time between inclusion and death
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763671
Show 55 study locations
| Principal Investigator: | Alexis CORTOT, MD | CHRU Lille | |
| Principal Investigator: | Benjamin BESSE, MD | Gustave Roussy, Cancer Campus, Grand Paris |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Intergroupe Francophone de Cancerologie Thoracique |
| ClinicalTrials.gov Identifier: | NCT01763671 |
| Other Study ID Numbers: |
IFCT-1103 |
| First Posted: | January 9, 2013 Key Record Dates |
| Last Update Posted: | March 14, 2023 |
| Last Verified: | March 2023 |
|
Lung cancer Paclitaxel bevacizumab IFCT |
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel Docetaxel Bevacizumab |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |