Clinical trial · Interventional
CAELYX Versus Paclitaxel HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
A Phase 3, Randomized, Open-Label, Comparative Study of CAELYX Versus Paclitaxel HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
The objective of this study is to compare the efficacy and safety of CAELYX versus Paclitaxel HCl in patients with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy. The primary endpoint is time to progression (TTP) following treatment with either CAELYX or Paclitaxel HCl; the secondary endpoints are response rates, time to response, duration of response,quality of life assessment, and survival following treatment with either CAELYX or Paclitaxel HCl. Up to a total of 438 protocol-eligible patients with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy will be enrolled in order to obtain 350 evaluable patients.
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 Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAELYX | Drug | Doxorubicin | ALIAS |
| Paclitaxel HCl | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 001
- interventionNames
- Drug: CAELYX
- type
- ACTIVE_COMPARATOR
- label
- 002
- interventionNames
- Drug: Paclitaxel HCl
Primary outcomes (1)
- measure
- To demonstrate noninferiority with respect to time to progression (TTP) for CAELYX/DOXIL treatment when compared to paclitaxel treatment.
- timeFrame
- 8 week intervals
Secondary outcomes (1)
- measure
- Response rates, time to response, duration of response,quality of life assessment, and survival following treatment with either CAELYX or Paclitaxel HCl.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven (i.e., not borderline) epithelial ovarian carcinoma * Measurable disease * Recurrence of disease or disease progression indicative of failure of first-line platinum-based chemotherapy * Disease-free from prior malignancies for \>5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Adequate renal creatinine (\<2.5 mg/dL (\<220 μmol/L)) \& liver function (aspartate amino transferase (AST) and alanine amino transferase (ALT) \<2 x upper limit of normal, alkaline phosphatase \<2.0 x upper limit of normal, except if attributed to tumor, and bilirubin \< upper limit of normal) Exclusion Criteria: * Pregnant or breast feeding * Life expectancy of \<3 months * Prior radiation therapy to more than one-third of hematopoietic sites within 30 days prior to first dose of study drug * Prior therapy with DOXIL or paclitaxel * Prior chemotherapy within 28 days of first dose of study drug (or 42 days if subject has received a nitrosourea or mitomycin) * Treated with high dose therapy supported by bone marrow or peripheral stem cell transplantation at any time
References
Publications (0)
Data not yet available