Status:
COMPLETED
IMPACT: A Randomized WOO Study of Novel Therapeutic Agents in Women Triaged to Primary Surgery for EOC
Lead Sponsor:
Haukeland University Hospital
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The study will be conducted in women with advanced (stage IIIa-IV) ovarian cancer of the histologic subtype high grade serous carcinoma (HGSOC) who are going through a diagnostic laparoscopy. They wil...
Detailed Description
The women who agree to participate in the study prior to the laparoscopic evaluation, will be allocated to different study groups according to the diagnostic evaluation performed as standard of care a...
Eligibility Criteria
Inclusion
- Patients must have a clinical diagnosis of advanced ovarian, tubal or primary peritoneal cancer. Advanced disease is defined as at least stage 3 ovarian cancer. Definition of stages will be according to the Norwegian guidelines (Norsk Gynekologisk Forening, Veileder i gynekologisk onkologi, Kapittel: Eggstokk-, tube-, bukhinnekreft. Revisjon 01.12.15). If the clinical staff in charge of the patients plan to perform cytoreductive surgery, the patient can participate in the study, irrespective of ECOG performance status. Patients must not have metastases to the central nervous system and/or carcinomatous meningitis.
- Age 18 years or above
- Primary treatment setting. No prior treatment for gynecological cancer. Women who have been treated surgically for cervical cancer or precancerous lesions on the cervix can be included if she has finished treatment a year or more before current diagnosis of ovarian cancer.
- Must have laboratory values as the following :
- White Blood Cells ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin ≥ 9g/dL (≥ 5.6 mmol/L)
- Creatinine ≤ 140 μmol/L; if creatinine is borderline, the creatinine clearance ≥ 40 mL/min;
- Bilirubin \< 20 % above the upper limit of normal
- ASAT and ALAT ≤ 2.5 the upper limit of normal
- Albumin ≥ 2.5 g/L
- HbA1c \< 8.0 %
- INR \< 2.0
- All laboratory tests for screening are taken maximum 14 days before start of treatment with study drug.
- Ability to understand a written informed consent document, and the willingness to sign it.
- Presence of adequate venous accesses for required study blood samples
Exclusion
- Inability to understand the information given and unable to consent and/or give the information requested, due to language, mental capacity, or disease.
- Inability to receive substances per os.
- Pregnancy. Pregnant women are excluded from this study, as terapeutic treatment for ovarian cancer includes teratogenic chemotherapy and surgical removal of the uterus and the ovaries.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational drug or its composites.
- History of dysregulated coagulation or known bleeding disorder.
- Patients known to be Hepatitis B surface antigen positive, who have human immune deficiency virus (HIV) infection, and patients known or suspected to have active Hepatitis C infection.
- Patients diagnosed or treated for other malignancy within 1 year of administration of the first dose of the study agent, or previously diagnosed with other malignancy and have residual disease. Patients with non-melanoma skin cancer or any type of carcinoma in situ will not be excluded if they have had a complete tumor resection.
- Currently participate or have participated within the last four weeks of the first dose of the study agent in other studies including medication of participants.
- Diagnosis of immune deficiency disorder or having received immunosuppressant treatment within the last 7 days before planned intake of the first dose of the study agent. Corticosteroids in physiologic doses can be acceptable.
- Histologic diagnosis of non-High grade serous ovarian cancer.
- Presence of active tumors in the central nervous system and/or carcinomatous meningitis.
- Presence of active infection requiring systemic treatment.
- Current diagnosis of bowel obstruction (i.e. ileus or subileus).
- Individuals with indication of a condition, treatment or aberrant laboratory results that either can effect the results of this study or the sustainance of participation, such as renal failure stage ≥ 4, heart failure ≥ New York Heart Association (NYHA) grade III, a medical history of severe psychiatric disease, or a current diagnosis of alkoholism or drug addiction.
Key Trial Info
Start Date :
May 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03378297
Start Date
May 4 2018
End Date
January 5 2023
Last Update
October 30 2024
Active Locations (2)
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1
Helse Bergen HF, Haukeland University Hospital
Bergen, Norway, 5021
2
Helse Stavanger HF, Stavanger University Hospital
Stavanger, Norway, 4068