Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

AGO Study Group63 enrolled

Overview

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.

OBJECTIVES: * Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with carboplatin in patients with gynecological tumors. * Determine the dose-limiting toxicity of this regimen in these patients. * Determine the kind, frequency, severity, and duration of adverse events in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of doxorubicin HCl liposome. Patients receive doxorubicin HCl liposome IV over 60 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 28 days for 6 courses. Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the MTD as above. Patients are followed at 4-6 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1 year.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma

Interventions

carboplatinDRUG

AUC 6 q4w

pegylated liposomal doxorubicin hydrochlorideDRUG

20/30/40 mg/qm q4w Dose finding study

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Universitaetsklinikum Charite

Berlin, Germany

Zentralkrankenhaus

Bremen, Germany

Outcomes

Primary Outcomes

DL DLT

Time frame: DLT during first 3 cycles

Data from ClinicalTrials.gov

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