Metastatic collecting duct carcinoma MedDRA version: 17.1 Level: LLT Classification code 10073252 Term: Carcinoma of the collecting ducts of Bellini System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Avastin
Pharmaceutical Form: Solution for infusion
Trade Name: CISPLATINE
Pharmaceutical Form: Solution for infusion
INN or
Sponsors
UNICANCER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-Patients with histologically confirmed metastatic collecting duct carcinoma, 2-Available tumor samples for centralized reading by anatomopathologist, 3-Patients with or without nephrectomy, 4-At least one measurable lesion as per RECIST criteria (RECIST v1.1), 5-No prior chemotherapy nor anti-angiogenic drugs (naive patients), 6- No irradiation within 4 weeks before inclusion, 7-Absolute neutrophil counts (ANC) = 1.5 x 10^9/L, 8- Platelets =100 x 10^9/L, 9- Hemoglobin =9 g/dL, 10- Hepatic function : AST and ALT = 1.5 x ULN (= 4 x ULN in case of liver metastases); total bilirubin = 1.5 x ULN; alkaline phosphatase =65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: 1. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment, 2. 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, 3. Evidence of current central nervous system (CNS) metastases or spinal cord compression. If CNS metastases are suspected, patient should undergo an MRI or CT-Scan of the brain (with contrast, if possible) within 28 days prior to inclusion, 4. Another histological type of renal cancer 5. 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), 6. Uncontrolled hypertension (=160 mm Hg systolic and/or = 90 mm Hg diastolic) while receiving medication, 7. 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, 8. LVEF value less than 50%, 9. Current or recent (within 2 weeks of study enrolment) initiation of aspirin, clopidogrel), oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes. 10. History of clinically significant hemorrhagic of thromboembolic events in the past six months, or known inherited predisposition to bleeding or thrombosis or History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment; History of haemoptysis = grade 2 (defined as = 2.5 mL bright red blood per episode) within 1 month of study enrolment, 11. Patients who underwent, according to the investigator, a significant surgery such as but not limited to , abdominal, thoracic or neurologic surgery within 28 days before the first treatment administration or patient with a wound that is not already healed at the first treatment administration or patients who underwent a minor surgical procedure including placement of a vascular access device, within 2 days of the first study treatment, 12. Patients with active ulcer, 13. Patients with untreated bone fracture, 14. Peripheral neuropathy grade = 2 (Toxicity Criteria-(CTCAE) v4.0), 15. Including patients with active infection requiring intravenous antibiotics at the time of first study treatment, 16. In the opinion of the investigator, any evidence of other severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or any other acute or chronic medical condition that would make the patient inappropriate with this study, 17. Immunocompromised patients, including known seropositivity for human immunodeficiency virus (HIV), 18. Known hypersensitivity to any component of the investigational drugs or excipients, 19. Pregnant or lactating women, 20. Person deprived of their liberty or under judicial protection (including guardianship), 21. Patients with significantly altere
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of gemcitabine plus platinum salt in combination with bevacizumab using a co-primary endpoint composed of Objective Response Rate (CR or PR according to RECIST criteria) and Progression-Free Survival rate at 6 months.; Secondary Objective: Evaluation of the Progression-free survival (PFS) Evaluation of the Overall Survival (OS) Evaluation of the Safety To set up several biological material bank resources (plasma sample, tumor and for patients who underwent nephrectomy, non tumor tissu) for further ancillary studies (molecular, immunologic and pharmacogenomic studies) ; Primary end point(s): The primary endpoint is composed of: - the objective response rate (CR or PR) according to RECIST criteria (V1.1) - the progression-free survival (PFS) rate at 6 months , PFS is defined as absence of disease progression or death ;Timepoint(s) of evaluation of this end point: _ | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression-free survival (PFS) will be calculated from the date of the first dose of trearment to the date of progression or death (whichever comes first), or last date with no progression; - The Overall Survival (OS) will be calculated from the date of the first dose of trearment to the date of death (whatever the cause) or the date of last follow-up; - The toxicity will be evaluated according to the NCI-CTC version 4.0; ;Timepoint(s) of evaluation of this end point: _ | — |
Countries
France
Contacts
Public ContactMuriel HABIBIAN
UNICANCER
Outcome results
None listed