Chemotherapy for Lung Cancer in HIV-positive Patients (CHIVA)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01296113 |
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Recruitment Status :
Completed
First Posted : February 15, 2011
Last Update Posted : September 20, 2017
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Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
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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 |
Show Detailed Description
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
| Experimental: A |
Drug: Chemotherapy
Pemetrexed + Carboplatin On D1 of a 21-day cycle:
Carboplatin dose in mg = 5 x (GFR + 25) GFR is estimated according to the MDRD equation for creatinine clearance • 4 cycles total |
Primary Outcome Measures :
- Disease-Control rate after 4 cycles [ Time Frame: 3-weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
Publications:
| 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 Key Record Dates |
| Last Update Posted: | September 20, 2017 |
| Last Verified: | September 2017 |
Additional relevant MeSH terms:
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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 |