Clinical trial · Interventional
Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer
PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES
- 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)
Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or without filgrastim in treating patients who have newly diagnosed stage III or stage IV epithelial ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brenner Tumor | Brenner Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Clear Cell Cystadenocarcinoma | Ovarian Clear Cell Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Endometrioid Adenocarcinoma | Ovarian Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Mixed Epithelial Carcinoma | — | UNRESOLVED | — |
| Ovarian Mucinous Cystadenocarcinoma | Ovarian Mucinous Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Serous Cystadenocarcinoma | Ovarian Serous Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Undifferentiated Adenocarcinoma | — | UNRESOLVED |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (paclitaxel, cisplatin, topotecan hydrochloride)
- description
- Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
- interventionNames
- Drug: paclitaxel
- Drug: cisplatin
- Drug: topotecan hydrochloride
- Biological: filgrastim
Primary outcomes (1)
- measure
- Maximally tolerated doses (MTDs) of the combination of paclitaxel, Topotecan, and cisplatin administered without and with G-CSF based on dose-limiting toxicities (DLT) graded according to GOG Common Toxicity Criteria
- timeFrame
- 3 weeks
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed epithelial ovarian carcinoma * No borderline ovarian carcinoma * Stage III/IV disease that has been suboptimally or optimally debulked * The following histologies are eligible: * Adenocarcinoma (unspecified) * Mucinous cystadenocarcinoma * Clear cell adenocarcinoma * Serous cystadenocarcinoma * Endometrioid adenocarcinoma * Transitional cell carcinoma * Malignant Brenner's tumor * Undifferentiated carcinoma * Mixed epithelial carcinoma * Extraovarian papillary serous cystadenocarcinoma * Measurable or evaluable disease * Performance status - GOG 0-1 * Enabling completion of at least 2 courses of therapy * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * No myocardial infarction within 6 months * No congestive heart failure * No unstable or uncontrolled angina * No history of cardiac arrhythmia requiring anti-arrhythmia medication * No uncontrolled hypertension * No hypersensitivity to E. coli-derived drug preparation * No active infection * No sensory neuropathy * No other malignancies within the past 5 years except nonmelanomatous skin cancer * No prior chemotherapy * No prior radiotherapy * Recovered from any recent surgery
References
Publications (0)
Data not yet available