Clinical trial · Interventional
Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix
A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
NCT00006482CI-TRIAL-00010016terminatedPhase 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 combining gemcitabine and cisplatin in treating patients who have refractory or recurrent 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapy and is considered incurable * Must have had 1 prior chemotherapy regimen for cervical cancer * No more than 1 prior chemotherapy regimen (single or combination drug therapy), unless used as a radiosensitizer * No prior chemotherapy for recurrent or persistent disease including retreatment with initial chemotherapy * Bidimensionally measurable disease * Ineligible for higher priority GOG protocol PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count at least lower limit of normal * Absolute neutrophil count at least 1,500/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT and alkaline phosphatase no greater than 3 times normal Renal: * Creatinine no greater than 2.0 mg/dL Other: * Not pregnant * Fertile patients must use effective contraception * No significant infection * No other malignancies within past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy for cervical cancer Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy for cervical cancer and recovered * No prior gemcitabine Endocrine therapy: * At least 3 weeks since prior endocrine therapy for cervical cancer Radiotherapy: * At least 3 weeks since prior radiotherapy for cervical cancer and recovered * No prior radiotherapy to more than 25% of marrow-bearing areas Surgery: * At least 3 weeks since prior surgery for cervical cancer and recovered Other: * No concurrent amifostine or other protective reagents * No prior anticancer therapy that contraindicates study
References
Publications (1)
- RESULTBrewer CA, Blessing JA, Nagourney RA, McMeekin DS, Lele S, Zweizig SL. Cisplatin plus gemcitabine in previously treated squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Feb;100(2):385-8. doi: 10.1016/j.ygyno.2005.09.009. Epub 2005 Nov 4. PMID 16271750