Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer (NCT00032162) | Clinical Trial Compass
CompletedPhase 1/2
Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
Germany63 participantsStarted 2001-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…