Clinical trial · Interventional
Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Patients With Ovarian Cancer
A Phase II Study Designed to Evaluate the Safety and Efficacy of the Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Early Relapse Patients (< 6 Months) With Ovarian Cancer, Overexpressing HER2, Previously Treated With Carboplatin-Paclitaxel
NCT00189579CI-TRIAL-00000845terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate whether or not the addition of Herceptin may be of benefit to a standard regimen of carboplatin-paclitaxel.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin | Drug | Trastuzumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older; patients with histologically proven diagnosis of ovarian cancer. * Patients with metastatic disease and an overexpression of HER2 (as determined by immunochemistry) * Patients who have progressed while receiving treatment, or within 6 months after completion of treatment. Patients must have received carboplatin and paclitaxel. * Patients who have received at minimum one line of chemotherapy * 3 weeks minimum since last treatment with chemotherapy must have elapsed * Patients must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) or an assessable cancer antigen (CA) 125 \> 1.25 x upper limit of normal (ULN) * Patients must have ECOG of 2 or less * Left ventricular ejection fraction (LVEF) of 50% or better * Patients have given their signed and verbal consent Exclusion Criteria: * Previous treatment with Herceptin or similar products affected growth factors (eg: Iressa) * Another experimental treatment in the previous 30 days * No overexpression of HER2 receptors * Patients having received high-dose chemotherapy or stem-cell interventions * Other cancers within the last 5 years * Patients with dyspnea at rest or requiring oxygen therapy
References
Publications (0)
Data not yet available
No reference posted for this study.