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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00052312
First received: January 24, 2003
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Endometrial Cancer
Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Progression-free survival as measured by Kaplan Meier and RECIST at 18 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course [ Designated as safety issue: Yes ]

Enrollment: 141
Study Start Date: September 2002
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052312

  Show 35 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Nicholas S. Reed, MD University of Glasgow
Study Chair: Giorgio Bolis, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00052312     History of Changes
Other Study ID Numbers: EORTC-55984, EORTC-55984
Study First Received: January 24, 2003
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

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
Cisplatin
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014