Ramucirumab and Carbo-Paclitaxel for Untreated Thymic Carcinoma / B3 Thymoma With Carcinoma (RELEVENT)

  • STATUS
    Recruiting
  • End date
    Jul 16, 2022
  • participants needed
    60
  • sponsor
    Marina Garassino
Updated on 26 January 2021
renal function
serum pregnancy test
measurable disease
carcinoma
warfarin
direct bilirubin
gilbert's syndrome
metastasis
neutrophil count
liver metastasis
aptt
anticoagulation therapy
thymic carcinoma
epithelial tumors
thymic neoplasm

Summary

This is a multicentric study. All patients with TET (thymic epithelial tumors) of any histological type will participate in the study. This is an open-label phase 2 study that will follow a Green-Dahlberg 2-stage design whose objective is to evaluate the activity and safety of the combination of ramucirumab (10 mg / kg) + carboplatin (AUC 5) and paclitaxel (200 mg / m2) in patients with relapsed and / or metastatic thymic carcinoma/ thymoma B3, in the first line (RELEVENT trial).

Description

Clinical and quality of life data will be collected for all treated patient. Based on the histological evaluation performed by each participating center, patients will be screened for inclusion in one of the four studies, based on the following criteria:

  • TOPS study only: all patients with A, AB, B1, B2, B3 without areas of carcinoma histology, diagnosed during or after 2018, that do not have a fresh tissue sample and screen failures of the RELEVENT and BIOTET study;
  • TRY registry: all patients with TETs diagnosed, treated or followed from 2010 to 2017 included (retrospective data collection);
  • BIOTET only: all patients with A, AB, B1, B2, B3 without areas of histology of the carcinoma that have a fresh tissue sample;
  • RELEVENT only: all patients with thymoma B3 and areas of carcinoma and pa-tients with thymic carcinoma who do not have a fresh tissue sample.

Patients with thymic carcinoma or thymoma B3 with areas of carcinoma will receive a centralized pathological review of the tumour block or slides and will be screened to participate in the Phase II RELEVENT pharmacological study.Histological diagnosis will be confirmed before screening.

Details
Condition Thymoma, Thymoma, Thymomas, thymic neoplasm, thymic carcinoma
Treatment Ramucirumab
Clinical Study IdentifierNCT03921671
SponsorMarina Garassino
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

provision of written informed consent before treatment initiation
pathologically confirmed thymic carcinoma and B3 thymomas, with areas of carcinoma locally advanced as per central histological revision, recurrent and/or metastatic, not amenable to potentially curative treatments
age>= 18 years old
provision of archival or fresh tissue (block or at least 15 charged slides 4M of thickness)
Blood and plasma sampling at baseline and at first clinical revaluation
measurable disease (defined according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1);7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) 1500/L, haemoglobin
g/dL (5.58 mmol/L), and platelets 100,000/L; 9. adequate coagulation
function as defined by International Normalized Ratio (INR) 1.5, and a partial
thromboplastin time (PTT) 5 seconds above the ULN (unless receiving
anticoagulation therapy). Patients receiving warfarin must be switched to low
molecular weight heparin and have achieved stable coagulation profile prior to
first dose of protocol therapy 10. adequate hepatic function as defined by a
total bilirubin 1.5times the upper limit of normal (ULN), (Except for patients
with Gilbert's syndrome who may only be included in the total bilirubin is <
0 x ULN or direct bilirubin < 1.5 x ULN) and aspartate transaminase (AST)
and alanine transaminase (ALT) 3.0 times the upper limit of normal (or 5.0
times the ULN in the setting of liver metastases) 11. adequate renal function
as defined by a serum creatinine 1.5 times the ULN, or creatinine clearance
(measured via 24-hour urine collection) 40 mL/minute (that is, if serum
creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate
creatinine clearance must be performed). The patient's urinary protein is
+ on dipstick or routine urinalysis (UA; if urine dipstick or routine
analysis is 2+, a 24-hour urine collection for protein must demonstrate <1000
mg of protein in 24 hours to allow participation in this protocol)
\. sexually active patients, must be postmenopausal, surgically sterile, or
using effective contraception (hormonal or barrier methods). Female patients
of childbearing potential must have a negative serum pregnancy test within 7
days prior to first dose of protocol therapy. 13. Prior radiation therapy is
allowed
In case of chest radiotherapy a 28 days interval is needed between the end of the radiation treatment and the start of treatment
In the case of focal or palliative radiation treatment a 7 days interval is needed from last radiation treatment to start of treatment (and provided that 25% or less of total bone marrow had been irradiated)
In the case of CNS radiation a minimum of 14 days interval is needed from the end of radiation treatment to start of treatment

Exclusion Criteria

previous systemic treatment for locally advanced/metastatic thymic carcinoma/B3 thymomas; patients treated in the neoadjuvant or adjuvant setting can be enrolled after discussion with PI
untreated CNS metastases. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 2 weeks prior to start of treatment, or after surgical resection performed at least 28 days prior to start of treatment. The patient may have no evidence of Grade 1 CNS haemorrhage based on pre-treatment Magnetic Resonance Imaging (MRI) or IV contrast CT scan (performed within 28 days before start of treatment)
any Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy
peripheral neuropathy G2History of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to first dose of protocol therapy
patient has experienced hemoptysis (defined as bright red blood or 1/2 teaspoon) within 2 months prior to first dose of protocol therapy
radiographic evidence of intra-tumour cavitation, radiologically documented evidence of major blood vessel invasion or encasement by cancer
history of uncontrolled hereditary or acquired thrombotic disorder
The patient has
cirrhosis at a level of Child-Pugh B (or worse) or
cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
clinically relevant congestive heart failure (NYHA II-IV) or symptomatic or poorly controlled cardiac arrhythmia
The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol therapy.uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) despite standard medical management
serious or no healing wound, ulcer, or bone fracture within 28 days prior to start of treatment
significant bleeding disorders, vasculitis, or experienced grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to start of treatment
history of GI perforation and / or fistulae within 6 months prior to start of treatment
bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhoea
peripheral neuropathy grade 2 (NCI-CTCAE v 4.0)
serious illness or medical condition(s) including, but not limited to, the following: -Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)- related illness
Active or uncontrolled clinically serious infection
Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumours treated curatively and without evidence of recurrence for at least 3 years prior to start of treatment
Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient ineligible for entry into this study
significant third-space fluid retention (for example, ascites or pleural effusion), and is not amenable for required repeated drainage
known allergy or hypersensitivity reaction to any of the treatment components
known history of active drug abuse
patient is pregnant or breastfeeding
major surgery within 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy
elective or planned major surgery to be performed during the course of the clinical trial
patient is receiving concurrent treatment with other anticancer therapy
patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents
Once-daily aspirin use (maximum dose 325 mg/day) is permitted
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