Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer. (BUCiL)
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Purpose
At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.
In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.
The question is to know if this strategy is feasible in lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Non-small Cell Lung Cancer Metastatic Nonsquamous Nonsmall Cell Neoplasm of Lung | Drug: Cisplatin Drug: Bevacizumab Drug: Pemetrexed | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Phase II Study Evaluating the Interest of the Re-introduction of Pemetrexed and Platinum (Cisplatin or Carboplatin) With Prolonged Angiogenic Blocking by Bevacizumab in Non Squamous Non Small Cell Lung Cancer of Advanced Stage. |
- Feasibility [ Time Frame: After 3 cycles ]Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence
- Control rate after the 2nd sequence [ Time Frame: After 3 cycles ]
- Response rate after the 1st sequence [ Time Frame: After 3 cycles ]
- Overall survival [ Time Frame: 12 months ]
- Quality of life [ Time Frame: During Sequence 2 : at the beginning and after 3 cycles ]
| Enrollment: | 118 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2017 |
| Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BUCiL
Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --> Sequence 2 Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control |
Drug: Cisplatin
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence
Drug: Bevacizumab
7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence
Drug: Pemetrexed
500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles for the 1st sequence and until progression for the 2nd sequence.
|
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation.
- Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic.
- Measurable disease (recist criteria)
- Age ≥18 years
- PS0 or 1
Exclusion Criteria:
- Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer
- History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years.
- Tumor invaded the big vessels or the proximal visible in TDM.
- History of adjuvant or neoadjuvant chemotherapy
Contacts and Locations
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): NCT01705184
| France | |
| Avignon - Institut Sainte-Catherine | |
| Avignon, France, 84918 | |
| Caen - Centre François Baclesse | |
| Caen, France, 14000 | |
| Caen - CHU Côte de Nacre | |
| Caen, France, 14000 | |
| Centre Hospitalier | |
| Chauny, France | |
| CH du Mans | |
| Le Mans, France | |
| Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques | |
| Marseille, France | |
| Mulhouse - CH | |
| Mulhouse, France, 68000 | |
| Nantes - Centre René Gauducheau | |
| Nantes, France, 44805 | |
| Hopital Tenon - Pneumologie | |
| Paris, France, 75020 | |
| HCL - Lyon Sud (Pneumologie) | |
| Pierre Bénite, France, 69495 | |
| Rennes - CHU | |
| Rennes, France, 35033 | |
| Strasbourg - NHC | |
| Strasbourg, France, 63000 | |
| Principal Investigator: | Jaafar BENNOUNA, MD | Centre René Gauducheau - Nantes |
More Information
Additional Information:
Publications:
| Responsible Party: | Intergroupe Francophone de Cancerologie Thoracique |
| ClinicalTrials.gov Identifier: | NCT01705184 History of Changes |
| Other Study ID Numbers: |
IFCT-1102 2012-002647-18 ( EudraCT Number ) |
| First Submitted: | October 5, 2012 |
| First Posted: | October 12, 2012 |
| Last Update Posted: | March 9, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
|
Stop and go Non-small cell lung cancer Non-squamous Bevacizumab |
Additional relevant MeSH terms:
|
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 Cisplatin Bevacizumab |
Pemetrexed Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |