Adaptive chemotherapy approach for relapsed ovarian cancer
A Multicentre Phase II Randomised Controlled Trial to Evaluate the Efficacy of Adaptive Therapy (AT) With Carboplatin, Based on Changes in CA125, in Patients With Relapsed Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer
This study is testing if adjusting the dose of carboplatin based on a blood marker can help women with relapsed ovarian cancer feel better and have fewer side effects from treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University College, London Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London) |
| Trial ID | NCT05080556 on ClinicalTrials.gov |
What this trial studies
This study compares standard carboplatin treatment with an adaptive regimen that modifies the carboplatin dose based on the serum biomarker CA125, which reflects tumor burden and patient response. The goal is to prolong sensitivity to carboplatin, extend tumor control, and reduce toxicity associated with chemotherapy. Participants will receive carboplatin, and their treatment will be adjusted according to their individual responses as measured by CA125 levels. This approach aims to optimize treatment outcomes for patients with relapsed platinum-sensitive ovarian cancer.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with high grade serous or endometrioid ovarian cancer who have previously responded to platinum-based chemotherapy.
Not a fit: Patients who have not previously received a PARP inhibitor or those with non-measurable disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment efficacy and reduce side effects for patients with relapsed ovarian cancer.
How similar studies have performed: Other studies have shown promise in using adaptive dosing strategies in chemotherapy, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female patients aged ≥18 years 2. ECOG performance status 0-2 3. Histologically proven diagnosis of high grade serous or high grade endometrioid carcinoma of the ovary, fallopian tube or peritoneum 4. Most recent regimen must have included platinum (cisplatin or carboplatin) 5. Must have previously received a PARP inhibitor 6. 6\. Must have responded to most recent platinum treatment by CT or MRI or by GCIG CA125 response criteria 7. Pre-trial CT or MRI-confirmed disease relapse ≥ 6 months after day 1 of the last cycle of platinum-containing chemotherapy (cisplatin or carboplatin) and requiring treatment with further platinum-based chemotherapy 8. Measurable disease by RECIST v1.1 on a CT scan conducted within 28 days prior to randomisation (Patient with non-measurable disease could be eligible if they meet GCIG CA125 progression criteria) 9. CA125 ≥ 100iU/l at screening 10. Agree to provide additional research blood samples at the same time as blood draws prior to each carboplatin treatment, 6-weekly during surveillance and at 12- weekly follow-up visit 11. Expected to be able to commence treatment within 28 days post randomisation 12. Adequate bone marrow function 13. Adequate liver function 14. Adequate renal function 15. Postmenopausal or women of child-bearing potential (WOCBP) must agree to have an urine or serum pregnancy test at screening for evidence of non-childbearing status and prior to trial treatment and use adequate contraception for duration of trial 16. Willing and able to give consent and able to comply with treatment and follow up schedule Exclusion Criteria: 1. Non-epithelial ovarian cancer, carcinosarcoma, low-grade serous and endometrioid carcinomas, mucinous \& clear-cell carcinomas 2. Patients requiring treatment with combination chemotherapy regimens 3. Patients with a known hypersensitivity to carboplatin 4. Persisting ≥ grade 2 CTCAE v5 adverse events/ toxicity (except alopecia and neuropathy) from previous anti-cancer treatment. 5. Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to randomisation. 6. Major surgery within 14 days before anticipated start of treatment and patients must have recovered from any effects of major surgery. 7. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicated the use of an investigation drug or puts the patients at high risk for treatment-related complications. 8. Other psychological, psychiatric, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results. 9. Malignancy treated within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1, grade 1 endometrial carcinoma. 10. Patients with symptomatic uncontrolled brain or meningeal metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. 11. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to randomisation. 12. Pregnant or breast-feeding women are excluded. Women of childbearing potential will be excluded unless effective methods of contraception are used from signing of the informed consent, throughout the period of taking study treatment and for at least 6 months after last dose of trial drug(s). 13. Inability to attend or comply with treatment or follow-up scheduling.
Where this trial is running
London
- University College London Hospitals — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: ACTOv Trial Coordinator
- Email: ctc.actov@ucl.ac.uk
- Phone: 02076794466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.