Clinical trial · Interventional
Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors
NCT00032162CI-TRIAL-00007028completedPhase 1 / Phase 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 I/II trial to study the effectiveness of combining liposomal doxorubicin with carboplatin in treating patients who have gynecologic cancer.
Conditions
Conditions (5)
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 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PLD
- description
- dose finding study of PLD in combination with Carboplatin
- interventionNames
- Drug: carboplatin
- Drug: pegylated liposomal doxorubicin hydrochloride
Primary outcomes (1)
- measure
- DL DLT
- timeFrame
- DLT during first 3 cycles
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed fallopian tube cancer, Muellerian mixed tumor, endometrial cancer, uterine sarcoma, ovarian cancer with sarcoma parts, or cervical cancer * No ovarian epithelial cancer PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * Karnofsky 70-100% Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin greater than 10.0 g/dL Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal Renal: * Glomerular filtration rate at least 60 mL/min Cardiovascular: * No atrial or ventricular arrhythmias * No congestive heart failure even if stabilized on medication * No New York Heart Association class III or IV heart disease * No myocardial infarction within the past 6 months Other: * No pre-existing sensory or motor neuropathy grade 2 or greater * No active infection * No other serious medical condition that would preclude study * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy Chemotherapy: * No more than 1 prior chemotherapy regimen for the malignancy * No other concurrent chemotherapy Endocrine therapy: * Prior hormonal therapy within the past 10 days allowed * No concurrent hormonal therapy Radiotherapy: * At least 6 weeks since prior radiotherapy to no more than 25% of bone marrow Surgery: * Not specified Other: * At least 30 days since prior experimental agents * No other concurrent therapies that would preclude study * No concurrent participation in another study
References
Publications (1)
- RESULTdu Bois A, Pfisterer J, Burchardi N, Loibl S, Huober J, Wimberger P, Burges A, Stahle A, Jackisch C, Kolbl H; Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom; Kommission Uterus. Combination therapy with pegylated liposomal doxorubicin and carboplatin in gynecologic malignancies: a prospective phase II study of the Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) and Kommission Uterus (AGO-K-Ut). Gynecol Oncol. 2007 Dec;107(3):518-25. doi: 10.1016/j.ygyno.2007.08.008. Epub 2007 Oct 25. PMID 17910981