Clinical trial · Interventional
Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
A Phase I Study of Sequential Prolonged Oral Topotecan (IND# 58,131) and Prolonged Oral Etoposide as Second Line Therapy in Ovarian, Peritoneal or Tubal Carcinoma
NCT00003967CI-TRIAL-00010434completedPhase 1ClinicalTrials.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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of topotecan plus etoposide in treating patients who have recurrent ovarian cancer, peritoneal cancer, 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, peritoneal, or tubal cancer Epithelial cell types Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell Malignant Brenner's tumor Adenocarcinoma not otherwise specified Measurable or evaluable disease No brain or leptomeningeal metastases No symptomatic bowel involvement of ovarian cancer Not eligible for higher priority GOG phase II or III study PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT/SGPT/GGT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Other: No septicemia or severe infection Body surface area at least 1 m2 Adequate intestinal function (i.e., does not require IV hydration or nutritional support) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 3 months prior to and during study No other malignancies within the past 5 years except curatively treated skin cancer No other severe medical problems that would prevent compliance No condition of the GI tract that would affect GI absorption and motility No severe gastrointestinal bleeding PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior topotecan, other camptothecin analogs, or etoposide At least 1 prior cisplatin/paclitaxel based regimen At least 3 weeks since prior chemotherapy and recovered No more than 2 prior cytotoxic chemotherapy regimens No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy for cancer Radiotherapy: At least 3 weeks since prior radiotherapy to no more than 10% of the bone marrow and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 28 days or 5 half lives since prior investigational drugs (including cytotoxic drugs) No concurrent metoclopramide or cisapride for maintaining gastric motility or emptying No chronic H2 antagonists, proton pump inhibitors, or antacids for gastritis, gastroesophageal reflux disease, or gastric or duodenal ulcers Intermittent antacids allowed, if no antacids 6 hours prior to and 90 minutes after topotecan
References
Publications (1)
- RESULTRose PG, Markman M, Bell JG, Fusco NL. Sequential prolonged oral topotecan and prolonged oral etoposide as second-line therapy in ovarian or peritoneal carcinoma: a phase I Gynecologic Oncology Group study. Gynecol Oncol. 2006 Aug;102(2):236-9. doi: 10.1016/j.ygyno.2005.12.003. Epub 2006 Jan 18. PMID 16412499