Clinical trial NCT05963334: Comparison of Weekly Versus Every Three Weeks of Carboplatin Plus Paclitaxel in Patients With Advanced Epithelial Ovarian Cancer
Official title: A Non-randomized Control Study Comparing Weekly Versus Every Three Weeks of Carboplatin Plus Paclitaxel in Patients With Advanced Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Epithelial Ovarian Cancer
Keywords: Carboplatin induced side effects
Patient safety
Acute and chronic kidney injury
Anemia, neutropenia and thrombocytopenia
Advanced epithelia ovarian cancer
Improved patient toleration
Patient counselling and education
Routine laboratory tests and tumor markers comparison
Additional biomarkers
Cystatin-C (Cys-C)
Neutrophil gelatinase associated lipocalin (NGAL)
Interleukin-18 (IL-18)
Hepcidin (HEPC)
Kidney injury marker-1 (KIM-1)
Quality of life
Health related quality of life outcomes
Progression free survival
Palliative care
Chemotherapy, surgery and non-pharmacological treatment of ovarian cancer
Functional assessment of cancer therapy for ovarian cancer (FACT-O)
Functional assessment of cancer therapy/gynecologic oncology group/neurotoxicity (FACT-GOG/NTX)
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Misr International University
First posted: 2023-07-27
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective open-label non-randomized control study
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to compare weekly versus three-week collective of carboplatin/paclitaxel in advanced epithelial ovarian cancer. The author's hypothesis was to study and correlate routine laboratory tests, clinical biomarkers and quality of life questionnaires between weekly and three-week standard carboplatin regimens in order to reveal any possible superiority for the weekly study arm.

Detailed description: Ovarian cancer as the fifth leading cause of death in women worldwide. Since most women suffer asymptomatic manifestations or nonspecific symptoms, subsequent diagnosis is very tricky and late most of the time. Carboplatin/paclitaxel has been among the first line options for treatment of ovarian cancer for decades however, account for a great of deal of adverse effects affecting patient safety. These side effects are dose related whereas, dose of carboplatin is calculated individually for each patient using the Calvert equation focusing on renal functions at baseline. Carboplatin adverse effects are believed to mainly affect the kidneys, hematological system and may cause neurotoxicity thus, exhibit quality of life deteriorations.

The study purpose was to investigate a triple correlation between 3 different aspects comparing the weekly dose versus the three-week dense dose of carboplatin/paclitaxel in treating advanced epithelial ovarian cancer.

Points of comparison:

1. Routine laboratory parameters in an attempt to identify the possible adverse effects accounted to each regimen focusing on hematological, renal, hepatic, and tumor marker panels.
2. Additional biomarkers including cystatin-C, neutrophil gelatinase associated lipocalin, hepcidin, kidney injury marker-1 and interleukin-18 assessing the probable incidence of acute kidney injury and anemia.
3. Quality of life analyzed by comparing functional assessment of cancer therapy-ovarian and functional assessment of cancer therapy/gynecologic oncology group-neurotoxicity surveys between both groups.

The study encouraged the patient right to be involved and consent to the assigned protocol

The correlation between all three aspects studied as of routine lab work, toxicity biomarkers and quality of life besides the economic burden aim to provide a decent patient tailored treatment regimen balancing efficacy and safety.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Cancer stage according to the International Federation of Gynecology and Obstetrics (FIGO) classification subdivided into the following categories; (I A, B, and C), II (A and B) III (A, B and C) and (IVA and B). Stage I: (tumor limited to the uterus (confined to the organ of origin) and subdivided into IA: below 5cm, IB : above 5 cm.

Stage II: Tumor extends beyond the uterus within the pelvis (invasion of surrounding organs) subdivided into IIA: adnexal involvement, IIB: involvement of other pelvic tissue.

Stage III: Tumor invades abdominal tissue (spread to nodes or tissue within the pelvis), subdivided into: IIIA: one site; IIIB: more than one site; IIIC: metastasis to the pelvic and/or para-aortic lymph node.

Stage IV: Tumor invades external organs to the uterus subdivided into IVA: tumor invading the bladder and/or rectum while IVB: distant metastasis(es).

-Indication for chemotherapy and life expectancy of at least 3 months Performance status is above and equal to 3 according to the Eastern Cooperative Oncology Group (ECOG).

Exclusion Criteria:

* Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
* Neutrophils (ANC) \< 2000 x mm3, platelets (PLT) \< 100,000 x mm3
* Inadequate renal function {creatinine (SCr) ≥1.5 x normal values} or liver function (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 x normal values).

Discontinuation criteria:

* Present or suspected hemorrhagic syndromes
* Inability to comply with protocol and follow-up
* Inability to access the study site for clinical visits
* Refusal of informed consent

Primary outcomes:
measure: Routine blood work and tumor markers
timeFrame: 6 cycles for each patient with a total of126 days
measure: Additional kidney and anemia biomarkers
timeFrame: 6 cycles for each patient with a total of126 days
measure: Improved quality of life
timeFrame: 6 cycles for each patient with a total of126 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pharmacology and toxicology department, Faculty of Pharmacy, Cairo University.
Study officials:
References: