Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin and cisplatin are more effective with or without paclitaxel in treating endometrial cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced, metastatic, and/or relapsed endometrial cancer.

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

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Doxorubicin; Liposomal doxorubicin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed endometrial epithelial carcinoma meeting at least 1 of the following criteria:

• Advanced metastatic and/or relapsed disease

• Locally advanced inoperable or unresectable disease

• No mixed mesodermal tumor and/or tumors showing evidence of sarcomatous elements

• Uterine papillary serous carcinoma allowed

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count greater than 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin greater than 10 g/dL (transfusions allowed)

Hepatic

• ALT and AST less than 2 times upper limit of normal (ULN)

• Alkaline phosphatase less than 2 times ULN

• Bilirubin less than 1.5 times ULN

Renal

• Creatinine less than 1.5 times ULN

• Creatinine clearance greater than 50 mL/min

Cardiovascular

• Normal baseline EKG

• Normal baseline LVEF on MUGA or echocardiogram for patients who received prior anthracyclines

Other

• Able to tolerate high-dose dexamethasone

• Must be considered fit for chemotherapy

• No uncontrolled infection

• No other malignancy within the past 5 years except successfully treated basal cell skin cancer or carcinoma in situ of the cervix

• No prior nervous or psychiatric disorder that would preclude study compliance

• No psychological, familial, sociological, or geographic condition that would preclude study participation

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 12 months since prior adjuvant chemotherapy

• Total dose of prior doxorubicin no greater than 200 mg/m^2

• Total dose of prior epirubicin no greater than 300 mg/m^2

Endocrine therapy

• At least 28 days since prior hormonal therapy for patients with partial or complete response after first-line treatment

Radiotherapy

• No prior radiotherapy to any area other than pelvis

• No concurrent radiotherapy

Surgery

• Not specified

Other

• No other concurrent anticancer medications