Clinical trial · Interventional
Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix
Phase II Investigation of Topotecan and Taxol in Patients With Recurrent/Metastatic Cancer of the Cervix
NCT00003065CI-TRIAL-00013305completedPhase 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent, persistent or metastatic cervical carcinoma (squamous or adenocarcinoma), with no potentially curative standard treatment * Measurable disease or evaluable disease PATIENT CHARACTERISTICS: Age: * 18 to physiological 60 Performance status: * ECOG 0-2 Life expectancy: * Greater than 2 months Hematopoietic: * WBC greater than 3000/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin less than 1.5 times normal * SGOT/SGPT less than 1.5 times normal Renal: * BUN less than 1.5 times normal * Creatinine less than 1.5 times normal * Creatinine clearance greater than 50 mL/min Other: * Ineligible for other high priority national or institutional study * Not pregnant or nursing * HIV negative * No prior malignancy except nonmelanoma skin cancer * No serious medical or psychiatric illness preventing treatment or informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Greater than 4 weeks since prior chemotherapy * No greater than 2 prior chemotherapy regimens * No prior taxane or camptothecin Endocrine therapy: * No concurrent hormonal therapy except that required for nondisease related conditions (e.g., insulin for diabetes) Radiotherapy: * Greater than 4 weeks since prior radiation therapy * No concurrent radiation therapy Surgery: * Greater than 4 weeks since prior surgery
References
Publications (1)
- RESULTTiersten AD, Selleck MJ, Hershman DL, Smith D, Resnik EE, Troxel AB, Brafman LB, Shriberg L. Phase II study of topotecan and paclitaxel for recurrent, persistent, or metastatic cervical carcinoma. Gynecol Oncol. 2004 Feb;92(2):635-8. doi: 10.1016/j.ygyno.2003.11.019. PMID 14766258