Does Cediranib Prevent Bowel Perforation in Platinum-resistant Ovarian Cancer (NCT07648745) | Clinical Trial Compass
CompletedPhase 2
Does Cediranib Prevent Bowel Perforation in Platinum-resistant Ovarian Cancer
United Kingdom30 participantsStarted 2018-05-14
Plain-language summary
Ovarian cancer can often grow and cause obstructions in the bowel. These obstructions usually cannot be removed with surgery and can be fatal. This trial is testing whether a drug called cediranib can be used safely together with paclitaxel chemotherapy to treat ovarian cancer in women at risk of bowel obstructions. All participants will receive the cediranib/paclitaxel combination, and if the cancer worsens the participant will stop receiving paclitaxel and may receive an additional drug, olaparib, together with cediranib.
Who can participate
Age range
16 Years
Sex
FEMALE
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
. Histologically confirmed, progressive, platinum-resistant or refractory, high-grade ovarian, fallopian tube or primary peritoneal cancer for which weekly paclitaxel would be a potential treatment option
. Aged 16 years or over
. At risk of bowel obstruction: features compatible with this include increasing abdominal pain and swelling, borborygmi, change in bowel habit, extensive serosal disease or dilated or tethered bowel on radiological investigation. One or more of these should be present in eligible patients. Previous bowel obstruction is permitted providing patients can take oral medication and there is no concern about absorption of oral medication. Recto sigmoid involvement is permitted
. Adequate haematological function: Hb ≥ 100 g/l, Neutrophils ≥ 1.5 x 109/l, Platelets ≥ 100 x 109/l; coagulation: INR \<1.4 (unless therapeutically anti-coagulated) and/or APPT ratio \<1.4
. Adequate renal function defined as GFR ≥50ml/min and Creatinine clearance ≥50 mL/min using modified Wright or Cockcroft-Gault formula
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
The number of patients free of grade III-V gastrointestinal perforation or fistula causally related to cediranib.
Timeframe: From date of registration until 28 days after the last dose of cediranib, or until death, whichever occurs first. Minimum assessment period: 18 weeks of cediranib treatment or until prior withdrawal/death.
. Adequate liver function: bilirubin ≤ 1.5 x ULN, transaminases ≤ 3 x ULN
. Any number of previous anti-cancer treatments permitted including weekly paclitaxel in the first-line setting
. Controlled hypertension permitted. Patients must have a blood pressure (BP) of ≤ Systolic BP (SBP):150/ Diastolic BP (DBP) 90 mmHg, with or without anti-hypertensive medication. BP measurements must be taken in the clinic setting by a medical professional within 2 weeks prior to starting study. A maximum of 3 anti-hypertensive medications are permitted and it is strongly recommended that patients who are on 3 anti-hypertensive medications be followed by a cardiologist or a primary care physician for management of BP while on study
Exclusion criteria
. Patients with a known hypersensitivity to olaparib, cediranib or paclitaxel or any of the excipients of the products
. Concurrent medical illness that would impact on compliance with the protocol including myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) or with features suggestive of MDS/AML
. Uncontrolled brain metastases or seizures. A scan to confirm the absence of brain metastases is not required. Central nervous system metastases:
. History of spinal cord compression unless after definitive treatment the patient has clinically stable disease (SD) for at least 28 days prior to starting IMPs. In the absence of these features and in an asymptomatic patient a scan to confirm the absence of brain metastases is not required
. Known positivity for Hep B, Hep C or HIV
. Resting ECG with QTc \> 470msec on 2 or more time points within a 24-hour period or family history of long QT syndrome
. Concomitant use of known strong CYP3A4/5 inhibitors such as such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir. Concomitant use of inducers or inhibitors (e.g., phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) is also excluded. The required washout period prior to starting olaparib is 2 weeks