Clinical trial · Interventional
Paclitaxel and Cisplatin as First-Line Treatment for Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer
A Phase II Study of Efficacy and Safety of Paclitaxel and Cisplatin Every 2 Weeks as the First-line Treatment of Patients With Ovarian Cancer Stage Ic-IV.
- 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 and cisplatin, 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 II trial is studying the side effects of giving paclitaxel together with cisplatin as first-line therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV ovarian epithelial 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 |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival
Secondary outcomes (3)
- measure
- Overall survival
- measure
- Objective response rate (complete and partial remission in patients with measurable disease)
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed epithelial adenocarcinoma of the ovary * Stage IC-IV disease * No known or clinical evidence of brain metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Hemoglobin must be ≥ 90 g/L * ANC ≥ 2 x 10\^9/L * Platelet count ≥ 100 x10\^9/L * Serum creatinine ≤ 115 μmol/L * Total bilirubin ≤ 25 μmol/L * Not pregnant or nursing * No other serious disease which could affect protocol compliance and results * No other prior malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix or squamous carcinoma of the skin * No peripheral neuropathy ≥ CTCAE version 3.0 grade 2 * No known hypersensitivity to any of the study drugs or their excipients * No drug addiction or alcoholism * No disorder which leads to the condition that contraindicates the use of the investigational drugs, or that may affect the patient's compliance with the study requirements PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for ovarian cancer
References
Publications (0)
Data not yet available