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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer; Hiv-positive	Drug: Chemotherapy	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	62 participants
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	May 2011
Actual Primary Completion Date :	January 2016
Actual Study Completion Date :	July 2017

Arms and Interventions

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Arm

Intervention/treatment

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

Outcome Measures

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Primary Outcome Measures :

1. Disease-Control rate after 4 cycles [ Time Frame: 3-weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

France
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Annemasse - CH
Ambilly, France, 74100
Annecy - CH
Annecy, France, 74374
Avignon - CH
Avignon, France
CH de la Côte Basque
Bayonne, France
CHU Besancon - Pneumologie
Besancon, France, 25000
Caen - CHU Côte de Nacre
Caen, France, 14000
CH Cahors
Cahors, France
CHU
Clermont-Ferrand, France
CH
Colmar, France
CH Compiègne - Pneumologie
Compiègne, France
Créteil - CHI
Créteil, France, 94000
CHU Grenoble - pneumologie
Grenoble, France, 38000
Le Mans - Centre Hospitalier
Le Mans, France, 72000
CH
Longjumeau, France
Hôpital de la Croix Rousse
Lyon, France
Hôpital Louis Pradel
Lyon, France
APHM - Hôpital Nord
Marseille, France, 13000
Montpellier - CHRU
Montpellier, France, 34295
Nevers - CH
Nevers, France, 58033
Centre Antoine Lacassagne
Nice, France
CHR d'Orléans La Source
Orléans, France
APHP - Hopital Tenon - Pneumologie
Paris, France, 75020
GH Paris Saint-Joseph
Paris, France
Hôpital Saint Antoine
Paris, France
Paris - Pitié-salpêtrière
Paris, France
Pau - CH
Pau, France, 64046
Centre François Magendie - hôpital du Haut-Lévèque
Pessac, France
HCL - Lyon Sud (Pneumologie)
Pierre Bénite, France, 69495
Reims - CHU
Reims, France, 51092
Rennes - CHU
Rennes, France, 35033
Saint Brieuc - CHG
Saint Brieuc, France, 22000
NHC - Pneumologie
Strasbourg, France, 63000
Suresnes - Hopital Foch
Suresnes, France, 92151
Thonon les bains - CH
Thonon les bains, France, 74200
Toulon - CHI
Toulon, France, 83000
CHU Toulouse - Pneumologie
Toulouse, France
Tourcoing - CH
Tourcoing, France, 59208
Tours - CHU
Tours, France, 37000
CH Valence
Valence, France

Sponsors and Collaborators

Intergroupe Francophone de Cancerologie Thoracique

Investigators

Principal Investigator:	Armelle LAVOLE, MD	AP-HP, Hôpital Tenon

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

IFCT official website 

Publications:

Lavolé A, Chouaïd 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.

Responsible Party:	Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:	NCT01296113 History of Changes
Other Study ID Numbers:	IFCT-1001
First Posted:	February 15, 2011
Last Update Posted:	September 20, 2017
Last Verified:	September 2017

Additional relevant MeSH terms:

HIV Seropositivity; HIV Infections; 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; Lentivirus Infections; Retroviridae Infections	RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Carboplatin; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors