Clinical trial · Interventional
Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer
Open-label, Multicenter, Phase I/II Trial to Evaluate Efficacy Safety of the Combination Therapy of Genexol-PM and Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel-loaded polymeric micelle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose and recommended phase II dose (Phase I)
- measure
- Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II)
Secondary outcomes (6)
- measure
- Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I)
- measure
- Safety profiles (Phase I)
- measure
- Objective response rate as measured by RECIST criteria (Phase II)
- measure
- Overall survival (Phase II)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced ovarian cancer * Measurable disease by RECIST criteria * No prior or concurrent CNS metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 6 months * Clinically acceptable blood, kidney, and spleen function * Not pregnant or nursing * Fertile patients must use effective contraception * No preexisting sensory or motor neuropathy ≥ grade 1 * No other malignancies within the past 5 years PRIOR CONCURRENT THERAPY: * No prior chemotherapy for ovarian cancer * No prior immunotherapy or hormonal therapy for ovarian cancer * No prior radiotherapy to the pelvis or abdominal cavity * More than 2 weeks since prior major surgery other than debulking surgery
References
Publications (0)
Data not yet available