Clinical trial · Interventional
Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer
A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube
NCT00003382CI-TRIAL-00010667terminatedPhase 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 combination chemotherapy consisting of gemcitabine and topotecan in treating patients with refractory or recurrent ovarian 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically documented refractory or recurrent ovarian epithelial or fallopian tube cancer * No borderline ovarian cancer * Extra-ovarian papillary serous tumors eligible * Must not be eligible for any higher priority phase II or III GOG protocol PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * SGOT no greater than 3 times upper limit of normal (ULN) * Bilirubin no greater than 1.5 mg/dL * Elevated levels of alkaline phosphatase allowed Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No angina pectoris or clinically significant multifocal uncontrolled cardiac dysrhythmias * No uncontrolled hypertension Other: * No other active malignancy * No prior malignancy within the past 5 years except nonmelanomatous skin cancer * No active infection * No underlying medical problem that would prevent compliance * No known hypersensitivity to E. coli-derived drug preparations * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Must have received at least 1 prior platinum- and paclitaxel-based regimen * At least 4 weeks since prior chemotherapy * No prior topotecan and/or gemcitabine * No prior chemotherapy for a different prior malignancy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to more than 10% of bone marrow * At least 2 weeks since limited field radiation therapy Surgery: * Not specified
References
Publications (1)
- RESULTChen MD, Fleming GF, Mitchell S, Horowitz I. A phase I trial of gemcitabine and topotecan in previously treated ovarian or peritoneal cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Jan;100(1):111-5. doi: 10.1016/j.ygyno.2005.07.114. Epub 2005 Sep 8. PMID 16150481