Liposome-Encapsulated Doxorubicin Citrate and Carboplatin in Treating Patients With Advanced or Metastatic Recurrent Endometrial Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well liposome-encapsulated doxorubicin citrate given together with carboplatin works in treating patients with advanced or metastatic recurrent endometrial cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University Innsbruck
• Treatments: Carboplatin; Citric Acid; Doxorubicin; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of endometrial carcinoma, including any of the following cellular types:

• Mixed Mullerian carcinoma

• Serous carcinoma

• Clear cell carcinoma

• Primary advanced (FIGO stage III or stage IV) or metastatic recurrent disease

• Disease not curable by surgery

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm with spiral CT scan or MRI

• No known cerebral metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 12 weeks

• Platelet count ≥ 100,000/mm^3

• ANC ≥ 1,500/mm^3

• Hemoglobin ≥ 10 g/dL

• Creatinine ≤ 1.25 times upper limit of normal (ULN)

• Bilirubin ≤ 1.25 times ULN

• AST/ALT < 3 times ULN

• Glomerular filtration rate ≥ 50 mL/min

• LVEF ≥ 50% by ECHO

• Fertile patients must use effective contraception

• No myocardial infarction within the past 6 months

• No NYHA class II-IV congestive heart failure

• No third degree or complete heart block unless a pacemaker is in place

• No other malignancy within the past 5 years

• No concomitant medical illness (e.g., uncontrolled infection, uncontrolled angina, or other relevant illness) that makes the prescribed treatments within this study unfeasible

• No known hypersensitivity to study drugs

• No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for disease recurrence

• At least 12 months since prior adjuvant therapy containing anthracyclines with cumulative doses not exceeding the following:

• Epirubicin 600 mg/m²

• Doxorubicin 300 mg/m²

• At least 6 months since prior adjuvant therapy containing platinum

• At least 4 weeks since completion of radiotherapy involving the whole pelvis

• No concurrent radiotherapy or planned radiotherapy after study

• No concurrent endocrine, immunological, or other anticancer therapy

• No concurrent participation in another investigational drug study