Status:
COMPLETED
Comparison of Weekly Versus Every Three Weeks of Carboplatin Plus Paclitaxel in Patients With Advanced Epithelial Ovarian Cancer
Lead Sponsor:
Cairo University
Collaborating Sponsors:
Misr International University
Conditions:
Advanced Epithelial Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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 routi...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2023
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05963334
Start Date
January 1 2015
End Date
June 6 2023
Last Update
July 27 2023
Active Locations (1)
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1
Pharmacology and toxicology department, Faculty of Pharmacy, Cairo University.
Cairo, Egypt, 12613