Sunitinib Malate and Combination Chemotherapy as Front-Line Therapy in Treating Patients With Met… (NCT00936832) | Clinical Trial Compass
WithdrawnPhase 2
Sunitinib Malate and Combination Chemotherapy as Front-Line Therapy in Treating Patients With Metastatic Rectal Cancer That Cannot Be Removed by Surgery
Stopped: because the sunitinib showed futility in anotehr trial
France0Started 2009-04
Plain-language summary
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, 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 more than one drug (combination chemotherapy) together with sunitinib malate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sunitinib malate together with combination chemotherapy works as front-line therapy in treating patients with metastatic rectal cancer that cannot be removed by surgery.
Who can participate
Age range
18 Years – 120 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.
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the rectum
* Lower pole of the tumor \< 12 cm from the anal margin
* Synchronous metastases of the liver and/or lung
* Unresectable or resectability uncertain according to the decision of a local multidisciplinary consultation
* Lesions measurable in 1 dimension by RECIST criteria (metastases and primary rectal cancer)
* No rectal obstruction requiring surgery or the emergency fitting of a prosthesis
* No CNS metastases
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine clearance ≥ 60 mL/min
* Hemoglobin ≥ 10 g/dL (transfusions allowed)
* FEV ≥ 50%
* QT interval ≤ 450 ms (in men) or ≤ 470 ms (in women)
* Total bilirubin ≤ 1.5 times upper limit of normal
* Serum albumin ≥ 25 g/L
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No history of another cancer except for nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
* History of other cancers allowed provided the patient has been disease-free \> 3 years
* None of the following:
* Congestive heart failure or coronary heart disease
* Myocardial infarction within the past year
* Uncontrolled hypertension (systolic BP \> 160 mm Hg or diastolic BP \> 100 mm Hg) despite optimal medical management
* No active severe rectal bleeding
* No liver failure
* No known Gilbert syndrome
* No severe uncontrolled infection
* No chro…
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
Response rate at 3 months as assessed by RECIST criteria
Trial details
NCT IDNCT00936832
SponsorFederation Francophone de Cancerologie Digestive