Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
A Phase I/II Study to Determine the Maximum Tolerated Doses of Oral Topotecan, Carboplatin and Paclitaxel Administered Every 21 Days to Patients With Epithelial Ovarian Cancer Stages IIb, IIc, III and 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 use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II, stage III, or stage 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Maximum tolerated dose and dose-limiting toxicity of topotecan
- measure
- Toxic effects
- measure
- Antitumor activity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IIB, IIC, III, or IV ovarian epithelial cancer * Measurable or evaluable lesion or microscopic residual disease after first surgery (phase II patients) * No brain and/or leptomeningeal metastases by CT scan or MRI unless asymptomatic without corticosteroid therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Hemoglobin at least 9.0 g/dL * WBC at least 3,500/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) unless liver metastases present * Alkaline phosphatase no greater than 2 times ULN\* * SGOT no greater than 2 times ULN\* NOTE: \*No greater than 5 times ULN if liver metastases present Renal: * Creatinine no greater than 1.5 times ULN * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic cardiac disease, including clinical congestive heart failure or arrhythmias requiring treatment * No myocardial infarction within the past 3 months Other: * No other malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix * No uncontrolled infection * No complete bowel obstruction or other condition that would affect GI absorption or motility * No concurrent medical condition for which treatment with platinum, taxane, or camptothecin analogues are contraindicated * No other concurrent medical conditions that would preclude study * No mental disease * No history of allergy to platinum or taxanes, including drugs containing cremophor (e.g., cyclosporine or vitamin K) * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * No prior camptothecin analogue * No prior chemotherapy for ovarian cancer * No other concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * No concurrent hormonal therapy other than estrogen replacement Radiotherapy: * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * At least 30 days or 5 half-lives since any prior investigational therapy * No other concurrent investigational therapy * No concurrent metoclopramide or cisapride
References
Publications (0)
Data not yet available