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NCT Number: NCT05963334

Comparison of Weekly Versus Every Three Weeks of Carboplatin Plus Paclitaxel in Patients With Advanced Epithelial Ovarian Cancer

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.

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Key information

Conditions

Advanced Epithelial Ovarian Cancer Agranulocytosis Anemia Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia Thrombocytopenia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pharmacology and toxicology department, Faculty of Pharmacy, Cairo University.

Cairo, 12613, Egypt

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carboplatin/Paclitaxel

Drug

Weekly dose versus every three weeks dense dose of carboplatin/paclitaxel regimen in advanced epithelial ovarian cancer.

Primary outcomes

  1. Routine blood work and tumor markers

    Time frame: 6 cycles for each patient with a total of126 days

    Quantitative continuous parameter assay of blood samples to measure hemoglobin gram/deciliter, total leukocyte count, platelets, neutrophils all in (number/unit liter), serum creatinine, blood urea nitrogen, uric acid, serum calcium in (milligram/deciliter), alanine aminotransferase, aspartate aminotransferase in (unit liter), albumin (gram liter), carcinoembryonic antigen (nano-gram milliliter), and cancer antigen-125 (unit milliliter)

    This was cross-referenced against the universal laboratory values to identify the degree of anemia, neutropenia, thrombocytopenia, calcium deficiency, kidney injury, liver toxicity, and tumor progression comparing pre-and post-treatment results for patients on each regimen separately and also compare post-treatment between the two regimens by end of treatment (weekly dose of carboplatin group and 3-week collective dense dose carboplatin regimens).

  2. Additional kidney and anemia biomarkers

    Time frame: 6 cycles for each patient with a total of126 days

    Cystatin-C ng/mL, Neutrophil gelatinase-associated lipocalin ng/mL, Interleukin-18 pg/mL, Kidney injury marker-1 ng/mL, and Hepcidin pg/mL

    Acute kidney injury to the glomerular capsule and proximal tubule was assessed by the increase in Cys-C, NGAL, KIM-1, and IL-18 Anemia and diminished renal clearance resembling kidney injury were measured by increased levels of HEPC

    Pre-and post-treatment concentrations were compared for patients on each carboplatin regimen & post-treatment concentration by the end of treatment between weekly and collective 3-week dense dose

    • Biomarkers were measured using ELISA reader
    • Absorbance was converted to serum concentration using the standard curve for each biomarker constructed using the readings for standard serial dilutions
    • Concentrations were used to compare regimens and outline the carboplatin dosing schedule with the least margin of toxicity

    (Higher marker levels outline greater toxicity)

  3. Improved quality of life

    Time frame: 6 cycles for each patient with a total of126 days

    Functional assessment of cancer therapy-ovarian (FACT-O) & functional assessment of cancer therapy/Gynecologic Oncology Group neurotoxicity (FACT-GOG-NTX)

    A 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). FACIT organization developed questions into 5 compartments: {Personal (PWB), Emotional (EWB), Social (SWB), Functional (FWB), Ovarian cancer (OC) & Neurotoxicity (NTX))

    Hard copies, consume 10-15 mins to fill, patients documented their responses, guideline reverse calculation & trial outcome indices analyzed

    Compared at baseline, post-treatment by the end of therapy for each group individually & post-treatment between both carboplatin regimens FACT-G total score = PWB + EWB + SWB + FWB FACT-O total score = PWB + EWB + SWB + FWB + OC FACT/GOG-Ntx total score = PWB + EWB + SWB + FWB + NTX FACT-O Trial Outcome Index (TOI) = PWB + FWB + OC FACT/GOG-Ntx Trial Outcome Index (TOI) = PWB + FWB + NTX

    High scores = enhanced QOL, low scores = poor QOL

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Misr International University

Registry information

Official study title

A Non-randomized Control Study Comparing Weekly Versus Every Three Weeks of Carboplatin Plus Paclitaxel in Patients With Advanced Epithelial Ovarian Cancer

Important dates

Study start
2015
Primary completion
2019
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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