Actively Recruiting
A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)
Led by National Cancer Institute, Naples · Updated on 2024-06-18
35
Participants Needed
1
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of CABOTEM study is to demonstrate the safety and activity of the Cabozantinib and Temozolomide combination in Lung and GEP-NENs patients, progressing after a first line therapy, including target therapies (everolimus, sunitinib) and / or chemotherapy, in the approved setting.
CONDITIONS
Official Title
A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years and older patients
- Signed informed consent confirming willingness to comply with study requirements
- Histological or cytological diagnosis of well differentiated lung and GEP-NENs (NET G1, NET G2, NET G3) progressing after first-line therapy or large cell neuroendocrine carcinoma with Ki67 < 55% progressed after platinum-based chemotherapy
- Radiological evidence of disease progression within 12 months prior to study entry
- Measurable disease by RECIST 1.1 criteria with progression within 12 months prior to study entry
- Adequate swallowing ability
- Both functional and non-functional tumors eligible
- Stable dose of somatostatin analogues for at least 2 months if used concurrently
- At least 4 weeks washout from prior targeted therapies
- At least 6 months washout from prior PRRT treatment
- ECOG performance status 0-2
- Adequate organ function including bone marrow, liver, and kidney function as specified
- Recovery from prior treatment toxicities unless clinically insignificant or stable
- Estimated life expectancy of at least 12 weeks
- Use of effective contraception during study and specified periods after treatment for fertile participants
- Negative pregnancy test within 14 days prior to first study drug administration for women of childbearing potential
- Ability and willingness to sign informed consent
You will not qualify if you...
- Any anticancer therapy within 4 weeks before study entry
- Previous treatment with temozolomide or cabozantinib
- Radiation therapy for bone metastasis within 2 weeks or other external radiation within 4 weeks before recruitment
- PRRT treatment within 6 months before study entry
- Ongoing complications from prior radiation or surgery
- Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 3 months
- Therapeutic anticoagulation with oral anticoagulants or platelet inhibitors
- Chronic hepatitis B infection
- Chronic corticosteroid or immunosuppressive treatment
- Serious illnesses including gastrointestinal disorders with high risk of perforation, cavitating pulmonary lesions, lesions invading major blood vessels (except portal vasculature), significant bleeding risk within 3 months, active infection including HIV/AIDS, serious non-healing wounds, malabsorption, uncontrolled hypothyroidism, dialysis requirement, or history of organ transplantation
- Uncontrolled congestive heart failure with cardiac ejection fraction less than 40%
- QTcF prolongation above specified limits or congenital long QT syndrome
- Rare hereditary conditions of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
- Major surgery within 3 months before study entry without complete healing
- Pregnant or breastfeeding women
- History of another malignancy within 2 years except superficial skin cancers
- Serious or unstable medical or psychiatric disorders interfering with safety or study compliance
- Chronic treatment with drugs contraindicated with cabozantinib or temozolomide according to product labels
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Institute of Naples
Naples, Campania, Italy, 80131
Actively Recruiting
Research Team
S
Salvatore Tafuto, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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