Clinical trial · Interventional
Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous Cell Carcinoma of the Cervix
NCT00006224CI-TRIAL-00010006terminatedPhase 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. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have persistent 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable
* Eligible subtypes:
* Adenocarcinoma
* Adenosquamous carcinoma
* Undifferentiated carcinoma
* Must have documented disease progression
* Histologic confirmation of original primary tumor required
* Bidimensionally measurable disease
* Ineligible for higher priority GOG protocol
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* GOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Platelet count at least 100,000/mm\^3
* Granulocyte 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 1.5 mg/dL
Other:
* No significant infection
* Not pregnant
* Fertile patients must use effective contraception
* No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent filgrastim (G-CSF)
Chemotherapy:
* No prior gemcitabine
* At least 3 weeks since other prior chemotherapy for cervical cancer and recovered
* No more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy)
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 3 weeks since prior radiotherapy for cervical cancer and recovered
Surgery:
* At least 3 weeks since prior surgery for cervical cancer and recovered
Other:
* No prior cancer treatment that would preclude studyReferences
Publications (1)
- RESULTSchilder RJ, Blessing J, Cohn DE. Evaluation of gemcitabine in previously treated patients with non-squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2005 Jan;96(1):103-7. doi: 10.1016/j.ygyno.2004.09.027. PMID 15589587