Chemotherapy for Lung Cancer in HIV-positive Patients
CHIVA
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
1 other identifier
interventional
61
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started May 2011
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 15, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedMarch 14, 2023
March 1, 2023
4.7 years
February 11, 2011
March 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-Control rate after 4 cycles
3-weeks
Study Arms (1)
A
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
- Estimated life expectancy ≥ 1 month,
- Covered by health insurance
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Annemasse - CH
Ambilly, 74100, France
Annecy - CH
Annecy, 74374, France
Avignon - CH
Avignon, France
CH de la Côte Basque
Bayonne, France
CHU Besancon - Pneumologie
Besançon, 25000, France
Caen - CHU Côte de Nacre
Caen, 14000, France
CH Cahors
Cahors, France
CHU
Clermont-Ferrand, France
CH
Colmar, France
CH Compiègne - Pneumologie
Compiègne, France
Créteil - CHI
Créteil, 94000, France
CHU Grenoble - pneumologie
Grenoble, 38000, France
Le Mans - Centre Hospitalier
Le Mans, 72000, France
CH
Longjumeau, France
Hôpital de la Croix Rousse
Lyon, France
Hôpital Louis Pradel
Lyon, France
APHM - Hôpital Nord
Marseille, 13000, France
Montpellier - CHRU
Montpellier, 34295, France
Nevers - CH
Nevers, 58033, France
Centre Antoine Lacassagne
Nice, France
CHR d'Orléans La Source
Orléans, France
APHP - Hopital Tenon - Pneumologie
Paris, 75020, France
GH Paris Saint-Joseph
Paris, France
Hôpital Saint Antoine
Paris, France
Paris - Pitié-salpêtrière
Paris, France
Pau - CH
Pau, 64046, France
Centre François Magendie - hôpital du Haut-Lévèque
Pessac, France
HCL - Lyon Sud (Pneumologie)
Pierre-Bénite, 69495, France
Reims - CHU
Reims, 51092, France
Rennes - CHU
Rennes, 35033, France
Saint Brieuc - CHG
Saint-Brieuc, 22000, France
NHC - Pneumologie
Strasbourg, 63000, France
Suresnes - Hopital Foch
Suresnes, 92151, France
Thonon les bains - CH
Thonon-les-Bains, 74200, France
Toulon - CHI
Toulon, 83000, France
CHU Toulouse - Pneumologie
Toulouse, France
Tourcoing - CH
Tourcoing, 59208, France
Tours - CHU
Tours, 37000, France
CH Valence
Valence, France
Related Publications (2)
Lavole A, Chouaid C, Baudrin L, Wislez M, Raguin G, Pialoux G, Girard PM, Milleron B, Cadranel J. Effect of highly active antiretroviral therapy on survival of HIV infected patients with non-small-cell lung cancer. Lung Cancer. 2009 Sep;65(3):345-50. doi: 10.1016/j.lungcan.2008.11.018. Epub 2009 Jan 9.
PMID: 19135758BACKGROUNDLavole A, Greillier L, Mazieres J, Monnet I, Kiakouama-Maleka L, Quantin X, Spano JP, Lena H, Fraisse P, Janicot H, Audigier-Valette C, Langlais A, Morin F, Makinson A, Cadranel J; French Cooperative Thoracic Intergroup (IFCT). First-line carboplatin plus pemetrexed with pemetrexed maintenance in HIV-positive patients with advanced non-squamous non-small cell lung cancer: the phase II IFCT-1001 CHIVA trial. Eur Respir J. 2020 Aug 27;56(2):1902066. doi: 10.1183/13993003.02066-2019. Print 2020 Aug.
PMID: 32444410RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Armelle LAVOLE, MD
AP-HP, Hôpital Tenon
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
February 11, 2011
First Posted
February 15, 2011
Study Start
May 1, 2011
Primary Completion
January 1, 2016
Study Completion
July 1, 2017
Last Updated
March 14, 2023
Record last verified: 2023-03