Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers (NCT01229111) | Clinical Trial Compass
TerminatedPhase 2
Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers
Stopped: Lack of Drug Supply
United States14 participantsStarted 2010-10
Plain-language summary
This phase II trial is studying how well giving cediranib maleate together with combination chemotherapy works in treating patients with advanced biliary cancers. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cediranib maleate together with combination chemotherapy may kill more tumor cells.
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:
* Patients with histopathological or cytopathological diagnosis of advanced biliary carcinoma (gallbladder cancer, cholangiocarcinoma, ampullary cancer) not amenable to conventional surgical approach are eligible
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral CT scan
* No patients with untreated brain metastases
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
* Life expectancy of greater than 12 weeks
* White blood cell (WBC)/leukocytes ≥ 3,000/μL
* Absolute neutrophil count ≥ 1,500/μL
* Platelets ≥ 100,000/μL
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 3 mg/dL
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) ≤ 2.5 times institutional upper limit of normal
* Creatinine within normal institutional limits OR calculated creatinine clearance ≥ 60 mL/min
* No patients with proteinuria not meeting the criteria below; urine sample must be tested by urine protein:creatinine (UPC) ratio or by urinalysis method within 1 week of starting study treatment; depending upon the testing method used, the following criteria must be met:
* UPC ratio must be \< 1.0; if UPC ratio is ≥ 1.0, a 24-hour urine specimen must be collected and must dem…
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.
1This trial was terminated before completing — do you know why it was stopped early, and does that affect what we can actually learn from its results about cediranib combined with chemotherapy for my type of biliary cancer?
2Since this was a Phase 2 trial measuring tumor response rates using RECIST criteria, does the available data suggest any signal of benefit strong enough to influence my treatment plan, even though the trial didn't fully complete?
3My diagnosis falls under biliary cancers, but this trial covered several specific subtypes like cholangiocarcinoma, gallbladder cancer, and periampullary adenocarcinoma — does the data from this trial apply to my particular subtype, or is it too limited to draw conclusions?
4Given that this trial is no longer recruiting, are there other active trials studying cediranib or similar anti-angiogenic drugs combined with chemotherapy for advanced biliary cancers that might be worth considering instead?
5Before looking at trials like this one, should I first explore whether standard first-line chemotherapy options — like gemcitabine-based regimens — have been fully exhausted in my case, and how would that affect my eligibility for future studies?
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
The Response Rate of Patients Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1