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

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ClinicalTrials.gov Identifier: NCT02363751
Recruitment Status : Recruiting
First Posted : February 16, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Tracking Information
First Submitted Date  ICMJE February 9, 2015
First Posted Date  ICMJE February 16, 2015
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2015)
Composite endpoint : Objective response rate / Progression-free survival [ Time Frame: 6 months ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2015)
  • Progression-free survival (PFS) [ Time Frame: 2 years max ]
    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
  • The Overall Survival (OS) [ Time Frame: 2 years max ]
    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
  • The toxicity will be evaluated according to the NCI-CTC scale version 4.0 [ Time Frame: 2 years max ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Gemcitabine+Platinium Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (GETUG-AFU 24)
Official Title  ICMJE Prospective Phase II Study of Gemcitabine Plus Platinium Salt in Combination With Bevacizumab (Avastin®) for Metastatic Collecting Duct Carcinoma
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Collecting Duct Carcinoma (Kidney)
Intervention  ICMJE Drug: Bevacizumab

Patients will be treated for a maximum of 6 (21days) chemotherapy cycles (Gemcitabine+platinium salt+bevacizumab).

In case of disease control (complete, partial or stable disease) treatment with bevacizumab 15mg/Kg monotherapy every 21 days will be continued until disease progression or until the end of the 24 months of follow-up.

Other Name: Avastin
Study Arms  ICMJE Experimental: 1
Patients will be treated for a maximum of 6 (21 days) chemotherapy cycles (Gemcitabine+platinium salt+bevcizumab)
Intervention: Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2015)
41
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sandra PELISSIER +33 1 44 23 55 68 s-pelissier@unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02363751
Other Study ID Numbers  ICMJE UC-0160/1210
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Constance THIBAULT, Dr Hôpital Européen Georges-Pompidou
Study Chair: Marc-Olivier TIMSIT, Dr Hôpital Européen Georges-Pompidou
PRS Account UNICANCER
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP