Clinical trial · Interventional
Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
Open Label Phase II Study on RFS 2000 (9-Nitro-camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced Ovarian Cancer
NCT00006230CI-TRIAL-00008097completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rubitecan | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven metastatic or unresectable locally advanced progressive ovarian cancer that has failed first line platinum and taxane based regimen * Refractory disease defined by a relapse within 1 year after completion of first line therapy * Sensitive disease defined by a relapse greater than 1 year after completion of first line therapy * Minimum of 1 target lesion that can be accurately measured in at least 1 dimension * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 times ULN (no greater than 5 times ULN if hepatic metastases present) Renal: * Creatinine no greater than 1.7 mg/dL Cardiovascular: * No ischemic heart disease within the past 6 months * Normal 12 lead electrocardiogram Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No unstable systemic disease or active uncontrolled infections * No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or cone biopsied carcinoma of the cervix * No psychological, familial, sociological, or geographical condition that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent filgrastim (G-CSF) with nitrocamptothecin Chemotherapy: * See Disease Characteristics * Greater than 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Greater than 4 weeks since prior radiotherapy Surgery: * Greater than 2 weeks since prior major surgery Other: * No other concurrent anticancer agents * No other concurrent investigational therapy
References
Publications (0)
Data not yet available
No reference posted for this study.