Clinical trial NCT02049047: Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy
Official title: Phase II Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thymoma and Thymic Carcinoma
Keywords: thymoma thymic carcinoma
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Given the high expression of IGF-1R and pAKT proteins in thymoma tissues, able to sensitize tumors to mTOR inhibition, and the anticancer activity of the mTOR inhibitors, clinical evaluation in thymoma and thymic carcinoma seems to be very interesting.

Patients will receive continuous treatment with oral everolimus 10 mg once daily.

Efficacy and safety profile of Everolimus will be evaluated.

Detailed description: Patients will receive continuous treatment with oral everolimus 10 mg once daily. Study drug will be self-administered orally (two 5 mg tablets) daily in a fasting state or with a light fat-free meal. Each cycle will be considered as 21 days of treatment; safety was assessed every 21 days. Tumor assessement will be done every two cycles. Treatment should be administered until documented disease progression, unacceptable toxicity, or patient refusal.

Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of invasive recurrent or metastatic thymoma or thymic carcinoma confirmed by pathologist.
* At least one prior platinum-containing chemotherapy regimen. There is no limit to the number of prior chemotherapy regimens received. Progressive disease should have been documented before entry into the study.
* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than 20 mm with conventional techniques or as greater than 10 mm with spiral CT scan.
* Patients must have recovered from toxicity related to prior therapy to at least to grade 1 (defined by CTCAE 3.0).
* No major surgery, radiation therapy, chemotherapy, biologic therapy (including any investigational agents), or hormonal therapy (other than replacement), within 4 weeks prior to entering the study.
* Life expectancy of at least 3 months.
* Performance status (ECOG)\<=2
* Negative pregnancy test (if female in reproductive years)
* Adequate organ and marrow function (as defined below)
* Leukocytes \>=3,000/mm, Absolute neutrophil count \>=1,500/mm, Hemoglobin\>= 9 g/dL, Platelets\>= 100,000/mm, Total bilirubin \>= 1.5 x institutional upper limit of normal (ULN), AST(SGOT)/ALT(SGPT)\>= 3 x institutional ULN (5x if LFT elevations due to liver metastases, )Creatinine \<= 1.5 x institutional ULN

Exclusion Criteria:

* Patients with symptomatic brain metastases. However, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 3 months without steroids may be enrolled at the discretion of the investigator.
* Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Pregnant or breast feeding women
* Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
* Current enrollment in or participation in another therapeutic clinical trial within 4 weeks preceding treatment start.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.

Primary outcomes:
measure: disease control rate
timeFrame: 6 months
Secondary outcomes:
measure: PFS
timeFrame: 6 months
measure: Duration of Response
timeFrame: 6 months
measure: OS
timeFrame: 6 months
measure: FDG-PET imaging relations
timeFrame: 6 weeks
measure: safety profile
timeFrame: 6 months
measure: biomarkers expression
timeFrame: 6 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zucali PA, De Pas T, Palmieri G, Favaretto A, Chella A, Tiseo M, Caruso M, Simonelli M, Perrino M, De Vincenzo F, Toffalorio F, Damiano V, Pasello G, Garbella E, Ali M, Conforti F, Ottaviano M, Cioffi A, De Placido S, Giordano L, Bertossi M, Destro A, Di Tommaso L, Santoro A. Phase II Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Cisplatin-Based Chemotherapy. J Clin Oncol. 2018 Feb 1;36(4):342-349. doi: 10.1200/JCO.2017.74.4078. Epub 2017 Dec 14.