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Advanced Epithelial Ovarian CancerPhase 1/2NCT05963334

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

A Phase 1/2 study testing Carboplatin/paclitaxel in people with Advanced Epithelial Ovarian Cancer, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Epithelial Ovarian Cancer
What is being tested?
Carboplatin/paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteEgypt
Study dates
1 Jan 2015to 6 Jun 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

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

    Cairo, 12613

Other trials in Egypt

About this study

Official title: A Non-randomized Control Study Comparing 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.

Read the 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.

Being tested
Carboplatin/paclitaxel
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)
Medical subject headings
Anemia, Neutropenia, Thrombocytopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carboplatin/paclitaxelDrug

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

Study groups in NCT05963334
Study groupRoleWhat they receive
Weekly dose of carboplatin / paclitaxel (n=21)ExperimentalPatients in this group received the weekly dose regimen, where the dose of carboplatin administered intravenously once/week was calculated using the Calvert equation to yield an area under the curve (AUC) = 2
Receives: Drug: Carboplatin/paclitaxel
3-Week collective dense dose of carboplatin / paclitaxel (n=28)Active comparatorPatients in this group received the three-week collective dose regimen, where the dose of carboplatin was administered intravenously once on day 1/ every three weeks (21 days) and was calculated using the Calvert equation to yield an AUC = 6
Receives: Drug: Carboplatin/paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Routine blood work and tumor markers

    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).

    Measured: 6 cycles for each patient with a total of126 days

  2. Additional kidney and anemia biomarkers

    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)

    Measured: 6 cycles for each patient with a total of126 days

  3. Improved quality of life

    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

    Measured: 6 cycles for each patient with a total of126 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start1 Jan 2015
  3. Primary completion30 Nov 2019
  4. Study completion6 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
prospective open-label non-randomized control study
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05963334
Sponsor's protocol ID
PT 1491
Status last verified
Jul 2023
First submitted
10 Jul 2023
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Study findings, Experimental module, Ethical approval, Patient consent, Inclusion criterion, Exclusion criteria, Baseline characteristics.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Carboplatin/paclitaxel in people with Advanced Epithelial Ovarian Cancer, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Routine blood work and tumor markers (time frame: 6 cycles for each patient with a total of126 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05963334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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