Study of Gemcitabine+Platinum Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (GETUG-AFU 24)
- Sponsor
- UNICANCER
- Study ID
- NCT02363751
- Phase
- PHASE2
- Status
- Completed
Conditions
- Collecting Duct Carcinoma (Kidney)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — DRUGPatients will be treated for a maximum of 6 (21days) chemotherapy cycles (Gemcitabine+platinum salt+bevacizumab). In case of disease control (complete, partial or stable disease) treatment with bevacizumab 15 mg/Kg monotherapy every 21 days will be continued until disease progression or until the end of the 24 months of follow-up.
Study Details
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.
Key Dates
- First listed
- Feb 16, 2015
- Start date
- Dec 31, 2014
- Status verified
- Mar 2021
- Primary completion
- Mar 31, 2020
- Completion
- Aug 31, 2020
Study Design
- Enrollment
- 36 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1Patients will be treated for a maximum of 6 (21 days) chemotherapy cycles (Gemcitabine+platinum salt+bevacizumab)
Primary Outcome Measure
Composite endpoint : Objective response rate / Progression-free survival [ Time Frame: 6 months ]