Chemotherapy for Lung Cancer in HIV-positive Patients

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique
• Treatments: Carboplatin; Pemetrexed

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