Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Objectives

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.

Entry Criteria

Disease Characteristics:

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

Prior/Concurrent Therapy:

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

Patient Characteristics:

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

Expected Enrollment

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.

Outline

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.

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 Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Matti Aapro, MD, Protocol chair (Contact information may not be current)		Ph: 41-22-372-4018

Back to Top