Rucaparib Maintenance Therapy in Advanced Cervical Cancer

• Status: Withdrawn
• Trial end date: 2019-10-10
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the efficacy of PARP inhibitor, rucaparib as maintenance therapy for locally advanced cervical cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordic Society for Gynaecologic Oncology; Nordic Society of Gynaecological Oncology - Clinical Trials Unit
• Collaborators: Belgian Gynaecological Oncology Group; Central and Eastern European Oncology Group; GCP-enhederne; GSO Global Clinical Research BV; Institute of Cancer Research, United Kingdom; North Eastern German Society of Gynaecological Oncology; North Eastern Germany Society of Gynaecologic Oncology; PGOG (Polish Gynaecologic Oncology Group); Princess Margaret Hospital, Canada
• Treatments: Rucaparib

Criteria

Inclusion Criteria:

1. Histologically confirmed squamous cell, adenocarcinoma or adenosquamous carcinoma of the cervix.

2. Patient must have completed definitive chemoradiation and is evaluated to be in complete remission 10-12 week's post definitive treatment.

3. Initial FIGO stage IIB with positive nodes (histological verification or verified by MRI/PET-CT), FIGO stages IIIA, IIIB, IVA; or any stage with para-aortic metastases (including IB and IIA with positive aortic nodes).

4. Toxicities resulting from definitive treatment must resolve to grade ≤1 prior to randomization.

5. Patient must consent that archival tumour tissue can be collected at the time of screening and used for translational studies.

6. Patient must consent to collection of whole blood and blood plasma during the study period. These samples will be stored and later used for translational studies.

7. Patient agrees to undergo all analysis; radiological examinations according to protocol.

8. The patient agrees to complete PROs (QoL questionnaire) during study treatment.

9. Patients must give informed consent.

10. Patients must be at least 18 years of age.

11. ECOG performance status 0-1

12. Serum albumin >30g/l.

13. Adequate organ function

• Absolute neutrophil count (ANC) ≥1,500/mcL

• Platelets >100,000/mcL

• Haemoglobin ≥ 9g/dl (no blood transfusions for 4 weeks prior entering the trial.)

• Serum creatinine ≤1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥50mL/min using Cockcroft-Gault formula.

• Total bilirubin ≤1.5x ULN.

• Alanine aminotransferase (ALT) ≤2.5x ULN

14. Life expectancy of at least 12 weeks.

15. Women of childbearing potential must use highly effective methods of birth control for the duration of study participation and for 6 months afterwards.

16. All patients: Patients should not donate blood or blood components while participating in this study and through 90 days after receipt of the final dose of IMP. -

Exclusion Criteria:

1. Histological types other than in inclusion criteria, like sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancers.

2. Concurrent cancer therapies or cancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biologic or hormonal therapy) within last 4 weeks.

3. Concurrent treatment with an investigational agent or participation in another clinical trial.

4. Previous malignant disease: patients are not eligible for the study if actively being treated of invasive cancer. Patients with previous malignant disease who are relapse-free and treatment-free for more than three years may enter this study. Patients with previous history of in-situ carcinoma of cervix, or non-invasive basal cell and squamous cell skin carcinoma can enter this trial.

5. Active infections or other serious underlying significant medical illness, abnormal laboratory finding or psychiatric illness/social situation that would, in the investigator's judgment, make the patient inappropriate for this study. Known active or chronic hepatitis C and/or B infection. Has known history of tuberculosis.

6. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.

7. Any evidence of distant metastases.

8. Significant cardiovascular diseases, including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months prior to randomization, congestive heart failure >NYHA II (New York Heart Association), severe peripheral vascular disease, clinically significant pericardial effusion.

9. Pregnancy or breastfeeding. Patients with preserved reproductive capacity, unwilling to use a medically acceptable method of contraception for the duration of the trial and for 6 months afterwards.

10. Known hypersensitivity to the trial drugs, or to their excipients.

11. Persons who have been committed to an institution by official or judicial order

12. Patients with dependency on the sponsor, investigator or study site -