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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Intergroupe Francophone de Cancerologie Thoracique
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT01296113
First received: February 11, 2011
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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
Hiv-positive
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: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01296113

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

Additional Information:
Publications:
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT01296113     History of Changes
Other Study ID Numbers: IFCT-1001
Study First Received: February 11, 2011
Last Updated: July 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Carcinoma, Non-Small-Cell Lung
HIV Seropositivity
Lung Neoplasms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014