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

NCT02363751 | Completed Phase 2 DMC

• 2 other identifiers: UC-0160/12102013-001179-19
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Collecting Duct Carcinoma (Kidney)

Keywords

Bellini; Metastatic; Chemotherapy; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Composite endpoint : Objective response rate / Progression-free survival

  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

  6 months

Secondary Outcomes (3)

• Progression-free survival (PFS)

  2 years max

• The Overall Survival (OS)

  2 years max

• The toxicity will be evaluated according to the NCI-CTC scale version 4.0

  2 years max

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

Patients 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.

Also known as: Avastin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed metastatic collecting duct carcinoma (medullary accepted),
• 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),
• Absolute neutrophil counts (ANC) ≥1.5 x 10⁹/L,
• Platelets ≥100 x 10⁹/L,
• Hemoglobin ≥9 g/dL,
• 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),
• Renal function : creatinine clearance ≥60 mL/min (MDRD calculation method) using cis-platin and \>30 mL/min when using carboplatin,
• Absence of proteinuria at baseline defined by \<0.3 g of protein on urine sample or \<0.5 g/24h on urine collection,
• 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.
• ECG with normal or clinically insignificant as per investigator's judgement sinus rhythm,
• ECOG Performance Status: 0 - 2,
• Estimated life expectancy ≥12 weeks,
• Patients who have received the information sheet, dated and signed the informed consent form,

You may not qualify if:

• 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,
• Another histological type of renal 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,
• LVEF value strictly less than 50%,
• Current or recent (within 2 weeks of study enrolment) initiation of aspirin, clopidogrel), oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes,
• 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,
• 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,
• Patients with active gastro-duodenal ulcer,
• Patients with untreated bone fracture,
• Peripheral neuropathy grade ≥2 (Toxicity Criteria-(CTCAE) v4.0),
• Patients with active infection requiring intravenous antibiotics at the time of first study treatment,
• 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,

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (19)

Institut de Cancérologie de l'Ouest-Site Paul Papin

Angers, 49333, France

Location

CHU Besançon

Besançon, 25030, France

Location

Hôpital Saint André

Bordeaux, 33075, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Hôpital Henri Mondor

Créteil, 94000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Paoli-Calmettes

Marseille, 13273, France

Location

ICM Val d'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

Institut de cancérologie de l'Ouest - Site René Gauducheau

Saint-Herblain, 44800, France

Location

CHU Strasbourg - Hôpital Civil

Strasbourg, 67091, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

CHR Bretonneau

Tours, 37044, France

Location

Gustave Roussy, Cancer Campus, Grand Paris

Villejuif, 94805, France

Location

Related Publications (1)

• Thibault C, Flechon A, Albiges L, Joly C, Barthelemy P, Gross-Goupil M, Chevreau C, Coquan E, Rolland F, Laguerre B, Gravis G, Pecuchet N, Elaidi RT, Timsit MO, Brihoum M, Auclin E, de Reynies A, Allory Y, Oudard S. Gemcitabine plus platinum-based chemotherapy in combination with bevacizumab for kidney metastatic collecting duct and medullary carcinomas: Results of a prospective phase II trial (BEVABEL-GETUG/AFU24). Eur J Cancer. 2023 Jun;186:83-90. doi: 10.1016/j.ejca.2023.03.018. Epub 2023 Mar 23.

  PMID: 37054556 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Constance THIBAULT, Dr

  Hôpital Européen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

• Marc-Olivier TIMSIT, Dr

  Hôpital Européen Georges-Pompidou

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 16, 2015
• Study Start: December 1, 2014
• Primary Completion: March 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

FR (19)