Clinical trial · Interventional
Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas
Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma
NCT00750386CI-TRIAL-00004904completedPhase 1 / Phase 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)
This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV 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 | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Paclitaxel/Carboplatin
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Determine the maximum tolerated dose and the response rate
- timeFrame
- Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes (2)
- measure
- Toxicity profile
- timeFrame
- Toxicity assessment on each cycle
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically- or cytologically- confirmed ovarian cancer requiring standard chemotherapy * Patients have to be chemotherapy naive * Patients may have undergone cytoreductive surgery, or this may have been omitted due to dissemination * Age \>18 years. * Performance status (WHO) 0-2 * Life expectancy of at least three months. * Adequate bone marrow function (Absolute neutrophil count \>1000/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3). * Adequate liver (Bilirubin\<1.5 times upper limit of normal and SGOT/SGPT\<2 times upper limit of normal) and renal function (creatinine\<2mg/dl) * Informed consent Exclusion Criteria: * Pregnant or nursing * Psychiatric illness or social situation that would preclude study compliance' * Other concurrent uncontrolled illness * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
References
Publications (0)
Data not yet available
No reference posted for this study.