Overview

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