Cabozantinib in Treating Patients With Locally Advanced or Metastatic Unresectable Adrenocortical… (NCT03370718) | Clinical Trial Compass
CompletedPhase 2
Cabozantinib in Treating Patients With Locally Advanced or Metastatic Unresectable Adrenocortical Carcinoma
United States18 participantsStarted 2018-02-26
Plain-language summary
This phase II trial studies how well cabozantinib works in treating patients with adrenal cortex cancer that has spread to nearby tissue, lymph nodes (locally advanced), or other places in the body (metastatic), and cannot be removed by surgery (unresectable). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histological confirmation of adrenocortical carcinoma (ACC) based on either: i). Weiss Score of \>= 3 in patients who had earlier surgical resection OR ii). biopsy results compatible with ACC in the context of clinical setting highly suggestive of ACC (adrenal mass \> 4 cm invading surrounding organs or associated with distant metastases).
* Locally advanced or metastatic disease not amenable to surgery with curative intent with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the investigator based on an assessment of all known disease sites by computerized tomography (CT) scan or magnetic resonance imaging (MRI) of chest/abdomen/pelvis within 28 days before the first dose of cabozantinib. In patients with intravenous (IV) contrast allergy or borderline renal function, CT without IV contrast or 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) CT may be used as clinically indicated.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Recovery to baseline or =\< grade 1 CTCAE v.4.0 from toxicities related to any prior treatments, unless adverse events (AEs) are clinically nonsignificant and/or stable on supportive therapy.
* Life expectancy of at least 3 months.
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 without colony stimulating factor support (obtained within 28 days prior to the first dose of cabozantinib).
* Platelets \>= 100,000/mm\^3 (obtained within 28 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free Survival (PFS) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria