Study of Gemcitabine+Platinum Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcino… (NCT02363751) | Clinical Trial Compass
CompletedPhase 2
Study of Gemcitabine+Platinum Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (GETUG-AFU 24)
France36 participantsStarted 2014-12
Plain-language summary
Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinum salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients should be aged ≥18 years at the inclusion,
✓. Available tumor samples for centralized reading by anatomopathologist,
✓. Patients with or without nephrectomy,
✓. At least one measurable lesion as per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1),
✓. No prior chemotherapy nor anti-angiogenic drugs ; Prior adjuvant chemotherapy of localised disease admitted if it is stopped for more than 12 months at the inclusion date.,
✓. No irradiation within 4 weeks before inclusion,
✓. Absolute neutrophil counts (ANC) ≥1.5 x 10⁹/L,
Exclusion criteria
✕. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment,
✕. Prior systemic treatment with chemotherapy or anti-angiogenic tyrosine kinase inhibitors such as axitinib, sunitinib, sorafenib, pazopanib, tivozanib, mTOR inhibitor (Temsirolimus or everolimus) and targeted VEGF drugs such as bevacizumab and VEGF trap,
✕. Evidence of current spinal cord compression or leptomeningeal disease. Please note that patients with asymptomatic brain metastases are eligible,
✕. Other malignancy within 3 years prior to inclusion (except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, and/or pT1/a bladder cancer),
✕. Uncontrolled hypertension (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic) while receiving medication,
✕. Cardio-vascular disorders: congestive heart failure ≥ NYHA II, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina,