Clinical trial · Interventional
UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer
NCT00072267CI-TRIAL-00018640completedPhase 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, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 7-hydroxystaurosporine | Drug | — | UNRESOLVED |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer * Progressive, persistent, or recurrent disease * Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy * Tumor lesions accessible for biopsy * Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator * No more than 2 prior chemotherapy regimens * At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin) * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 12 weeks Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN Renal * Creatinine no greater than ULN OR * Creatinine clearance at least 50 mL/min Cardiovascular * No history of coronary artery disease * No symptomatic cardiac dysfunction * No cardiac pathology by electrocardiogram\* NOTE: \*Patients with symptomatic coronary artery disease must undergo an electrocardiogram Pulmonary * No symptomatic pulmonary dysfunction Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 8 weeks after study participation * No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents * No insulin-dependent diabetes mellitus * Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator * No other concurrent uncontrolled illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior biologic therapy and recovered Chemotherapy * See Disease Characterisitcs * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No prior topotecan * No other prior topoisomerase I inhibitors Endocrine therapy * More than 4 weeks since prior hormonal therapy and recovered Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 40% of bone marrow * No prior mediastinal irradiation Surgery * More than 4 weeks since prior surgery and recovered Other * No other concurrent anticancer therapy * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients
References
Publications (0)
Data not yet available
No reference posted for this study.