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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT01296113
First received: February 11, 2011
Last updated: March 9, 2016
Last verified: March 2016
  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: May 2011
Estimated Study Completion Date: December 2016
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

  Eligibility

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

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: March 9, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on December 05, 2016