|Phase II||Treatment||Closed||20 to 75||EORTC-55872|
I. Determine the antitumor activity of the combination adriamycin/cisplatin and single-agent adriamycin in patients with advanced primary endometrial cancer that is beyond the stage of local treatment and in patients with recurrent disease who have received no prior chemotherapy. II. Determine the toxicity of both treatment arms in similar groups of patients.
Histologically proven, advanced or recurrent adenocarcinoma of the uterine corpus ineligible for radiotherapy or progestin treatment Measurable or evaluable, progressive disease outside previously irradiated areas required, with the following not acceptable as sole disease sites: Pleural effusions Ascites Bone lesions detectable only by bone scan Sclerotic bone metastases No brain involvement or leptomeningeal disease
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Ineligible for progestin therapy More than 4 weeks since hormone therapy with resolution of all toxicities Radiotherapy: Ineligible for further radiotherapy More than 4 weeks since prior radiotherapy with resolution of all toxicities Surgery: Not specified
Age: 20 to 75 Performance status: Not specified Hematopoietic: WBC at least 4,000 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dl (26 micromoles/liter) Renal: Creatinine no greater than 1.5 mg/dl (132 micromoles/liter) OR Creatinine clearance at least 60 ml/min Cardiovascular: No uncontrolled hypertension (diastolic blood pressure over 110 mm Hg) No CHF No MI within 1 year No serious arrhythmias Other: No uncontrolled bacterial infection No uncontrolled or potentially active sites of infection (e.g., fistulae, abscess) No poor medical risk because of nonmalignant systemic disease No prior or concurrent other malignancy except adequately treated nonmelanomatous skin cancer
Initially, 20 patients will be treated on each arm; 5 additional patients will be entered for each response observed in the first 20 patients. A maximum of 20 additional patients per arm may be entered.
Randomized study. Arm I: 2-Drug Combination Chemotherapy. Doxorubicin, Adriamycin, ADR, NSC-123127; Cisplatin, cis-Platinum, CDDP, NSC-119875. Arm II: Single-Agent Chemotherapy. ADR.Published Results
Aapro MS, van Wijk FH, Bolis G, et al.: Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group. Ann Oncol 14 (3): 441-8, 2003.[PUBMED Abstract]
Aapro M, Bolis G, Chevallier B, et al.: An EORTC-GCCG randomized phase II trial of doxorubicin (DOX) versus DOX-cisplatin (CDDP) in endometrial carcinoma. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-885, 275, 1994.
Trial Lead Organizations
European Organization for Research and Treatment of Cancer
|Matti Aapro, MD, Protocol chair (Contact information may not be current)|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.