Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.

NCT01705184 | Completed Phase 2

• 2 other identifiers: IFCT-11022012-002647-18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer Metastatic; Nonsquamous Nonsmall Cell Neoplasm of Lung

Keywords

Stop and go; Non-small cell lung cancer; Non-squamous; Bevacizumab; IFCT

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence

  After 3 cycles

Secondary Outcomes (4)

• Control rate after the 2nd sequence

  After 3 cycles

• Response rate after the 1st sequence

  After 3 cycles

• Overall survival

  12 months

• Quality of life

  During Sequence 2 : at the beginning and after 3 cycles

Study Arms (1)

BUCiL

EXPERIMENTAL

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; Drug: Bevacizumab; Drug: Pemetrexed

Interventions

Cisplatin DRUG

75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence

BUCiL

Bevacizumab DRUG

7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence

BUCiL

Pemetrexed DRUG

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.

BUCiL

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intergroupe Francophone de Cancerologie Thoracique: lead

Study Sites (12)

Avignon - Institut Sainte-Catherine

Avignon, 84918, France

Location

Caen - Centre François Baclesse

Caen, 14000, France

Location

Caen - CHU Côte de Nacre

Caen, 14000, France

Location

Centre Hospitalier

Chauny, France

Location

CH du Mans

Le Mans, France

Location

Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

Marseille, France

Location

Mulhouse - CH

Mulhouse, 68000, France

Location

Nantes - Centre René Gauducheau

Nantes, 44805, France

Location

Hopital Tenon - Pneumologie

Paris, 75020, France

Location

HCL - Lyon Sud (Pneumologie)

Pierre-Bénite, 69495, France

Location

Rennes - CHU

Rennes, 35033, France

Location

Strasbourg - NHC

Strasbourg, 63000, France

Location

Related Publications (3)

• Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400. doi: 10.1200/JCO.2005.03.0106.

  PMID: 16421419 BACKGROUND

• Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.

  PMID: 22341744 BACKGROUND

• Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, Andre T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.

  PMID: 19786657 BACKGROUND

Related Links

• IFCT website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Bevacizumab; Pemetrexed

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Officials

• Jaafar BENNOUNA, MD

  Centre René Gauducheau - Nantes

  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: October 5, 2012
• First Posted: October 12, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: October 1, 2017
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

FR (12)