Clinical trial · Interventional
Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
NCT00030472CI-TRIAL-00010014terminatedPhase 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 liposomal doxorubicin 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 |
|---|---|---|---|
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma (SCC) of the cervix * Persistent or recurrent progressive disease * Must have failed local therapeutic measures and considered incurable * 1 prior chemotherapeutic regimen for SCC of the cervix required * Initial treatment may include high-dose therapy, consolidation, or extended therapy * Ineligible for a higher priority GOG protocol * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * Target lesion may not be within a previously irradiated field PATIENT CHARACTERISTICS: Age: * Any age Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count at least 100,000/mm3 * Absolute neutrophil count at least 1,500/mm3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No congestive heart failure * No unstable angina * No myocardial infarction or new cardiac arrhythmia in the past 6 months Other: * No active infection requiring antibiotics * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * 1 prior noncytotoxic biologic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic cytostatic regimen for recurrent or persistent disease management) * At least 3 weeks since prior biologic or immunologic therapy for SCC of the cervix Chemotherapy: * See Disease Characteristics * No prior doxorubicin or doxorubicin HCl liposome * 1 prior noncytotoxic cytostatic regimen allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic biologic regimen for recurrent or persistent disease management) * No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens * Recovered from prior chemotherapy Endocrine therapy: * At least 1 week since prior hormonal therapy for SCC of the cervix * Concurrent hormone replacement therapy allowed Radiotherapy: * See Disease Characteristics * Recovered from prior radiotherapy Surgery: * Recovered from prior surgery Other: * At least 3 weeks since other prior therapy for SCC of the cervix * No prior anticancer treatment that precludes study
References
Publications (1)
- RESULTRose PG, Blessing JA, Lele S, Abulafia O. Evaluation of pegylated liposomal doxorubicin (Doxil) as second-line chemotherapy of squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Aug;102(2):210-3. doi: 10.1016/j.ygyno.2005.11.048. Epub 2006 Feb 14. PMID 16478630