Clinical Trials /

Study of Gemcitabine+Platinium Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (GETUG-AFU 24)

NCT02363751

Description:

Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinium salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma.

Related Conditions:
  • Collecting Duct Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Gemcitabine+Platinium Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (GETUG-AFU 24)
  • Official Title: Prospective Phase II Study of Gemcitabine Plus Platinium Salt in Combination With Bevacizumab (Avastin®) for Metastatic Collecting Duct Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: UC-0160/1210
  • NCT ID: NCT02363751

Conditions

  • Collecting Duct Carcinoma (Kidney)

Interventions

DrugSynonymsArms
BevacizumabAvastin1

Purpose

Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinium salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma.

Trial Arms

NameTypeDescriptionInterventions
1ExperimentalPatients will be treated for a maximum of 6 (21 days) chemotherapy cycles (Gemcitabine+platinium salt+bevcizumab)
  • Bevacizumab

Eligibility Criteria

        Inclusion Criteria:

          1. Patients should be aged ≥ 18years at the inclusion,

          2. Patients with histologically confirmed metastatic collecting duct carcinoma (medullary
             accepted),

          3. Available tumor samples for centralized reading by anatomopathologist,

          4. Patients with or without nephrectomy,

          5. At least one measurable lesion as per RECIST criteria (RECIST v1.1),

          6. 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.,

          7. No irradiation within 4 weeks before inclusion,

          8. Absolute neutrophil counts (ANC) ≥ 1.5 x 109/L,

          9. Platelets ≥ 100 x 109/L,

         10. Hemoglobin ≥ 9 g/dL,

         11. 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 < 2 x ULN (≤ 4 x ULN in case of bone
             metastases),

         12. Renal function : creatinine clearance ≥ 60 mL/min (MDRD calculation method) using
             cis-platin and > 30mL/min when using carboplatin,

         13. Absence of proteinuria at baseline defined by < 0.3 g of protein on urine sample or <
             0.5 g/24h00 on urine collection,

         14. Prothrombin time (TP) or partial thromboplastin time (PTT) strictly less than 50%
             deviation from normal limits, of international normalized ratio (INR) strictly below
             2, Note: The use of full-dose oral or parenteral anticoagulants as well as aspirin or
             clopidogrel is permitted as long as the INR or a PTT is within therapeutic limits
             (according to the medical standard of the institution) and the patient has been on a
             stable dose of anticoagulants for at least two weeks at the time of study enrolment.
             Prophylactic use of anticoagulants is allowed.

         15. ECG with normal or clinically insignificant as per investigator's judgement sinus
             rhythm,

         16. ECOG Performance Status: 0 - 2,

         17. Estimated life expectancy ≥ 12 weeks,

         18. Patients who have received the information sheet, dated and signed the informed
             consent form,

         19. Patient of child-bearing potential (for female patient: study entry after a menstrual
             period and a negative pregnancy test) must agree to use two medically acceptable
             methods of contraception (one for the patient and one for the partner) during the
             study and for 6 months after the last study treatment intake.

         20. Patients must be willing and able to comply with scheduled visits, treatment plan,
             laboratory tests and other study procedures,

         21. Patients affiliated to the Social Security System,

        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 spinal cord compression or leptomeningeal disease. Please note
             that patients with asymptomatic brain metastases are eligible,

          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 strictly 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 or 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 gastro-duodenal ulcer,

         13. Patients with untreated bone fracture,

         14. Peripheral neuropathy grade ≥ 2 (Toxicity Criteria-(CTCAE) v4.0),

         15. 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 altered mental status prohibiting the understanding of the
             study or with psychological, familial, sociological or geographical condition
             potentially hampering compliance with the study protocol and follow-up schedule or any
             condition which, in the opinion of the investigator, would preclude participation in
             this trial. Those conditions should be discussed with the patient before registration
             in the trial.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Composite endpoint : Objective response rate / Progression-free survival
Time Frame:6 months
Safety Issue:
Description:The primary endpoint is composed of: the objective response rate (CR or PR) according to RECIST criteria (V1.1) on the basis of measurable lesions defined at baseline, the progression-free survival (PFS) rate at 6 months , PFS is defined as the absence of disease progression or death

Secondary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:2 years max
Safety Issue:
Description:Progression-free survival (PFS) will be calculated from the date of the first dose of treatment to the date of progression or death (whichever comes first), or last date with no progression
Measure:The Overall Survival (OS)
Time Frame:2 years max
Safety Issue:
Description:The Overall Survival (OS) will be calculated from the date of the first dose of treatment to the date of death (whatever the cause) or the date of last follow-up
Measure:The toxicity will be evaluated according to the NCI-CTC scale version 4.0
Time Frame:2 years max
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:UNICANCER

Trial Keywords

  • Bellini
  • Metastatic
  • Chemotherapy
  • Bevacizumab

Last Updated

October 31, 2017