Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00063999
First received: July 8, 2003
Last updated: April 23, 2009
Last verified: April 2009

July 8, 2003
April 23, 2009
August 2003
January 2008   (final data collection date for primary outcome measure)
Duration of overall survival [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00063999 on ClinicalTrials.gov Archive Site
Duration of progression-free survival [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer

RATIONALE: Drugs used in chemotherapy such as doxorubicin, cisplatin, paclitaxel, and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.

PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with stage III, stage IV, or recurrent endometrial cancer.

OBJECTIVES:

  • Compare the efficacy of doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs carboplatin and paclitaxel, in terms of survival, in patients with stage III or IV or recurrent endometrial cancer.
  • Determine whether estrogen/progesterone receptor status provides prognostic information in patients treated with these regimens.
  • Compare the toxicity profile of these regimens, specifically neurotoxicity and infection, in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients accrued as of 04/17/06 are stratified according to disease status(measurable or recurrent disease vs non-measurable stage III or IV disease with pelvic radiotherapy vs non-measurable stage III or IV disease without pelvic radiotherapy). Patients are randomized to 1 of 2 treatment arms. Patients with LVEF < 50% at randomization who are initially randomized to arm I are immediately crossed over to arm II.

  • Arm I: Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12.
  • Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1.

In both arms, treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at weeks 6, 15, and 26 of study therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 900 patients (450 per treatment arm) will be accrued for this study within approximately 5 years.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Endometrial Cancer
  • Biological: filgrastim
    Given by injection
  • Drug: carboplatin
    Given IV
  • Drug: cisplatin
    Given IV
  • Drug: doxorubicin hydrochloride
    Given IV
  • Drug: paclitaxel
    Given IV
  • Active Comparator: Arm I
    Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Biological: filgrastim
    • Drug: cisplatin
    • Drug: doxorubicin hydrochloride
    • Drug: paclitaxel
  • Experimental: Arm II
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
Not Provided
January 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial carcinoma

    • FIGO stage III or IV or recurrent disease
  • Must know estrogen and progesterone status of the primary tumor
  • Poor potential for curative treatment by radiotherapy and/or surgery
  • At least 1 unidimensionally measurable lesion (for patients with stage III disease only)

    • At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR at least 10 mm by spiral CT scan
    • Disease in a previously irradiated field acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin normal
  • ALT no greater than 3 times upper limit of normal

Renal

  • Creatinine no greater than 1.6 mg/dL

Cardiovascular

  • LVEF at least 50%
  • Cardiac conduction abnormalities or dysfunction allowed at the investigator's discretion
  • No third-degree or complete heart block without a pacemaker
  • No uncontrolled angina
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class II -IV heart failure
  • No symptoms of congestive heart failure

Other

  • Not pregnant or nursing
  • Fertile patients must use effective non-hormonal contraception during and for at least 2 months after study participation
  • No other invasive malignancy within the past 5 years except patients who have nonmelanoma skin cancer or have received prior chemotherapy for that malignancy
  • No serious uncontrolled infection
  • No serious peripheral neuropathy
  • No other concurrent medical illness that would preclude study therapy
  • No circumstances that would preclude study completion or follow-up
  • No sensitivity to Escherichia coli-derived drug preparations
  • No uterine carcinosarcoma or other non-epithelial uterine malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy allowed
  • No concurrent biologic therapy

Chemotherapy

  • No prior cytotoxic chemotherapy (including radiotherapy sensitization) for this or any other malignancy

Endocrine therapy

  • Prior hormonal therapy allowed
  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy to the whole pelvis or over 50% of the spine
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium channel blockers) are allowed at the investigator's discretion
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Japan
 
NCT00063999
CDR0000305940, GOG-0209
Not Provided
Philip J. DiSaia, Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: David S. Miller, MD Simmons Cancer Center
National Cancer Institute (NCI)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP