Clinical trial · Interventional
A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer
A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer
NCT02026921CI-TRIAL-00013281completedPhase 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)
A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive relapse of epithelial ovarian, peritoneal or tubal cancer. Hypothesis: Treatment with this combination in second line is safe and with a low frequency of neurologic side effect.
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 Epithelial Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carboplatin and docetaxel
- description
- Intravenous infusion every 3 weeks Carboplatin plus docetaxel
- interventionNames
- Drug: Carboplatin
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Safety
- timeFrame
- Up to 30 days after last chemotherapy course
- description
- Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 2.0). All toxicities observed within 30 dayes of last chemocourse will be included.
Secondary outcomes (2)
- measure
- Response rate
- timeFrame
- Up to 30 dayes after last chemotherapy course
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Epithelial carcinoma of ovarian, peritoneal or fallopian tube origin. * Female * age above 18 years * WHO performance status 0-2 * Life expectancy \> 3 months * Previous treatment with one platinum and taxane containing regimen. * Platinum and taxane sensitive relapse * At least one evaluable/measurable lesion. * Adequate hematologic, renal and liver function * Consent form signed and dated before inclusion Exclusion Criteria: * Prior treatment with more than one line of chemotherapy * Concurrent severe and/or uncontrolled co-morbid medical condition. * History of previous or concurrent malignancy within the previous 5 years • History of prior serious allergic reactions such as anaphylactic shock * Pregnant or lactating women (or potentially fertile women not using adequate contraception) * Peripheral neuropathy \> Grade 2 * History of allergy to drugs containing the excipient TWEEN 80®. * Concomitant administration of any other experimental drug under investigation or concurrent treatment with any other anti-cancer therapy * Clinical evidence of brain metastases
References
Publications (0)
Data not yet available
No reference posted for this study.