Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00052312 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: September 24, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometrial Cancer | Drug: cisplatin Drug: doxorubicin hydrochloride Drug: paclitaxel | Phase 2 |
OBJECTIVES:
- Compare the overall survival of patients with locally advanced, metastatic, and/or relapsed endometrial cancer treated with doxorubicin and cisplatin with or without paclitaxel.
- Compare the toxicity of these regimens in these patients.
- Compare the progression-free survival at 18 months of patients treated with these regimens.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (0 vs 1 vs 2), metastatic disease (M0 vs M1), prior pelvic radiotherapy for pelvic recurrence (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV over 30 minutes, paclitaxel IV over 3 hours, and cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive doxorubicin and cisplatin as in arm I. Quality of life is assessed at baseline, before each course, after courses 3 and 6, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, quality of life is assessed every 3 months.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 141 participants |
Allocation: | Randomized |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Trial Of Adriamycin (A) Cisplatin (P) Chemotherapy Versus Paclitaxel (T) Adriamycin (A) And Cisplatin (P) In Patients With Metastatic/Relapsed Or Locally Advanced Inoperable Endometrial Cancer |
Study Start Date : | September 2002 |
Actual Primary Completion Date : | September 2006 |
- Progression-free survival as measured by Kaplan Meier and RECIST at 18 months
- Overall survival as measured by Kaplan Meier after each course, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter
- Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052312

Study Chair: | Nicholas S. Reed, MD | University of Glasgow | |
Study Chair: | Giorgio Bolis, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
ClinicalTrials.gov Identifier: | NCT00052312 History of Changes |
Other Study ID Numbers: |
EORTC-55984 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | September 24, 2012 |
Last Verified: | September 2012 |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma endometrial papillary serous carcinoma |
Additional relevant MeSH terms:
Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Paclitaxel Liposomal doxorubicin Albumin-Bound Paclitaxel Cisplatin |
Doxorubicin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |