Chemotherapy for Lung Cancer in HIV-positive Patients (CHIVA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Intergroupe Francophone de Cancerologie Thoracique
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique Identifier:
First received: February 11, 2011
Last updated: February 12, 2015
Last verified: February 2015
This is a phase II, multicenter, non-randomized, open-label study evaluating the combination of pemetrexed plus carboplatin in HIV-positive patients with lung cancer.

Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Evaluating the Efficacy and Safety of Carboplatin Plus Pemetrexed in Human Immunodeficiency Virus Positive (HIV+) Patients With Stage III (Not Amenable to Radiation or Inoperable) or Stage IV Nonsquamous Non Small Cell Lung Cancer

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Disease-Control rate after 4 cycles [ Time Frame: 3-weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 62
Study Start Date: May 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Chemotherapy

Pemetrexed + Carboplatin

On D1 of a 21-day cycle:

  • Pemetrexed 500 mg/m² IV in 10 minutes followed 30 minutes later by:
  • Carboplatin AUC 5 in 30 minutes in 100 ml sterile water or 5% glucose or physiological serum. The carboplatin dose will be calculated by the Calvert formula with a target AUC of 5 mg/mL.min as follows:

Carboplatin dose in mg = 5 x (GFR + 25) GFR is estimated according to the MDRD equation for creatinine clearance

• 4 cycles total

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • NSCLC histologically (highly recommended) and/or cytologically confirmed, stage III (non-irradiable or inoperable) or stage IV (according to 2009 TNM classification), with other than predominantly squamous histology
  • HIV seropositivity (previous or inaugural), irrespective of CD4 count or viral load
  • Presence of at least one measurable lesion (RECIST v1.1)
  • Subject having signed the informed consent form,
  • Subject who, in the investigator's opinion, will be able to comply with the requirements and constraints of the study
  • Age ≥ 18 years ≤ 75 years,
  • WHO performance status: 0, 1 or 2
  • Weight loss ≤ 10% of total body weight in the month before inclusion
  • Estimated life expectancy ≥ 1 month,
  • Covered by health insurance

Exclusion Criteria:

  • Bronchial cancer already treated (other than endoscopic deobstruction)
  • Cancer which is amenable to surgery or radiation (curative),
  • Squamous cell lung cancer or mixed small cell and non-small cell cancer, small cell lung cancer
  • Creatinine clearance (MDRD) < 45 mL/min
  • Severe hypersensitivity to any of the study products or excipients
  • Severe disease or uncontrolled systemic disease (unstable or decompensated respiratory disease, cardiac, hepatic or renal disease, uncontrolled opportunistic infection)
  • Significant abnormality in CBC-platelets (Hb <9 g/dL, PNN <1500 / mm3, platelets < 100,000 / mm3)
  • Significant abnormality in liver tests (AST, ALT > 3x ULN, and <5 in case of liver metastases),
  • Women of childbearing age without effective contraception; pregnant or breastfeeding women
  • Subject who cannot take vitamin B12, folic acid or corticosteroids
  • Diffuse interstitial pneumonia
  • Any geographical situation or psychological condition that precludes full understanding and compliance with the protocol
  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 identifier: NCT01296113

Contact: Elodie AMOUR
Contact: Franck MORIN

Centre Hospitalier du Pays d'Aix Recruiting
Aix-en-Provence, France
Contact: Thierry ALLEGRE   
Annemasse - CH Recruiting
Ambilly, France, 74100
Contact: Dominique LEDUC, Dr   
Annecy - CH Recruiting
Annecy, France, 74374
Contact: stéphane HOMINAL, Dr   
CH de la Côte Basque Recruiting
Bayonne, France
Contact: Sophie SCHNEIDER   
CHU Besancon - Pneumologie Recruiting
Besancon, France, 25000
Contact: Virginie Westeel, Pr   
Caen - CHU Côte de Nacre Recruiting
Caen, France, 14000
Contact: Gerard ZALCMAN, Pr   
CH Cahors Recruiting
Cahors, France
Contact: Patricia BARRE   
CHU Recruiting
Clermont-Ferrand, France
Contact: Henri JANICOT   
CH Recruiting
Colmar, France
Contact: Lionel MOREAU   
CH Compiègne - Pneumologie Recruiting
Compiègne, France
Contact: Stéphanie DEHETTE   
Créteil - CHI Recruiting
Créteil, France, 94000
Contact: Isabelle Monnet, Dr   
CHU Grenoble - pneumologie Recruiting
Grenoble, France, 38000
Contact: Denis Moro-Sibilot, Pr   
Principal Investigator: Denis Moro-Sibilot, Pr         
Le Mans - Centre Hospitalier Recruiting
Le Mans, France, 72000
Contact: Olivier MOLINIER, Dr   
CH Recruiting
Longjumeau, France
Contact: Gérard OLIVIERO   
Hôpital Louis Pradel Recruiting
Lyon, France
Contact: Nicolas GIRARD, MD   
Hôpital de la Croix Rousse Recruiting
Lyon, France
APHM - Hôpital Nord Recruiting
Marseille, France, 13000
Contact: Fabrice BARLESI, Dr   
Montpellier - CHRU Recruiting
Montpellier, France, 34295
Contact: Xavier Quantin, Dr   
Nevers - CH Recruiting
Nevers, France, 58033
Contact: Dominique Herman, Dr   
Centre Antoine Lacassagne Terminated
Nice, France
CHR d'Orléans La Source Recruiting
Orléans, France
Contact: Adrien DIXMIER   
Hôpital Saint Antoine Terminated
Paris, France
GH Paris Saint-Joseph Recruiting
Paris, France
Contact: Jean-Pierre TREDANIEL   
APHP - Hopital Tenon - Pneumologie Recruiting
Paris, France, 75020
Contact: Armelle LAVOLE, MD   
Paris - Pitié-salpêtrière Recruiting
Paris, France
Contact: Laurent TAILLADE, MD   
Pau - CH Recruiting
Pau, France, 64046
Contact: Aldo RENAULT, Dr   
Centre François Magendie - hôpital du Haut-Lévèque Recruiting
Pessac, France
Contact: Rémi VEILLON, Dr   
HCL - Lyon Sud (Pneumologie) Recruiting
Pierre Bénite, France, 69495
Contact: Pierre-Jean Souquet, Dr   
Reims - CHU Recruiting
Reims, France, 51092
Contact: Lidia PETIT, Dr   
Rennes - CHU Recruiting
Rennes, France, 35033
Contact: Hervé LENA, Dr   
Saint Brieuc - CHG Recruiting
Saint Brieuc, France, 22000
Contact: Daniel Coëtmeur, Dr   
NHC - Pneumologie Recruiting
Strasbourg, France, 63000
Contact: Philippe Fraisse, Dr   
Suresnes - Hopital Foch Recruiting
Suresnes, France, 92151
Contact: Hélène Doubre, Dr   
Thonon les bains - CH Recruiting
Thonon les bains, France, 74200
Contact: Philippe ROMAND, Dr   
Toulon - CHI Recruiting
Toulon, France, 83000
Contact: Clarisse Audigier-Valette, Dr   
CHU Toulouse - Pneumologie Recruiting
Toulouse, France
Contact: Christophe Herman, Dr   
Tourcoing - CH Recruiting
Tourcoing, France, 59208
Contact: Emilie PLUQUET, Dr   
Tours - CHU Recruiting
Tours, France, 37000
Contact: Eric Pichon, Dr   
CH Valence Recruiting
Valence, France
Contact: Robert RIOU   
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Principal Investigator: Armelle LAVOLE, MD AP-HP, Hôpital Tenon
  More Information

Additional Information:
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique Identifier: NCT01296113     History of Changes
Other Study ID Numbers: IFCT-1001
Study First Received: February 11, 2011
Last Updated: February 12, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lung Diseases
Neoplasms by Site
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Thoracic Neoplasms
Virus Diseases processed this record on November 24, 2015