Brief Title
Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Official Title
A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III & IV or Recurrent Endometrial Carcinoma
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating
patients who have stage III, stage IV, or recurrent endometrial cancer.
Detailed Description
OBJECTIVES:
- Determine whether the addition of paclitaxel, using filgrastim (G-CSF) support, to
standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of
objective response, progression-free survival, or overall survival in patients with
stage III, stage IV, or recurrent endometrial carcinoma.
- Compare the toxicities of these two regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive doxorubicin IV over 15-30 minutes, followed immediately by
cisplatin IV over 1 hour.
- Arm II: Patients receive doxorubicin and cisplatin as in arm I on day 1. On day 2,
patients receive paclitaxel IV over 3 hours. Patients also receive filgrastim (G-CSF)
subcutaneously beginning on day 3 and continuing for at least 10 days.
Courses are repeated every 21 days. Treatment continues for up to 7 courses in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study
within 21 months.
Study Phase
Phase 3
Study Type
Interventional
Condition
Endometrial Cancer
Intervention
filgrastim
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
240
Start Date
December 1998
Primary Completion Date
June 2004
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary stage III, stage IV, or recurrent endometrial
carcinoma
- Very poor potential for cure by radiotherapy or surgery alone or in combination
- Measurable disease
- Disease in an irradiated field as the only site of measurable disease allowed
provided 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
- Platelet count at least 100,000/mm^3
- Granulocyte count at least 1,500/mm^3
Hepatic
- SGPT no greater than 3 times upper limit of normal
- Bilirubin normal
Renal
- Creatinine no greater than 1.6 mg/dL
Cardiovascular
- LVEF at least 50% within past 6 months
- No uncontrolled angina
- No third-degree or complete heart block unless a pacemaker is in place
Neurologic
- No serious peripheral neuropathy
Other
- No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer
- No uncontrolled infection
- No sensitivity to E. coli-derived drug preparations
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior biologic therapy allowed
- No concurrent biologic therapy
Chemotherapy
- No prior cytotoxic chemotherapy, including chemotherapy used for radiation
sensitization
- No prior chemotherapy for any prior malignancy
Endocrine therapy
- Prior hormone therapy allowed
- No concurrent hormone therapy
Radiotherapy
- At least 4 weeks since prior radiotherapy to the whole pelvis or to over 50% of the
spine
Surgery
- Not specified
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gini F. Fleming, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00003691
Organization ID
CDR0000066794
Secondary IDs
GOG-0177
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Gini F. Fleming, MD, Study Chair, University of Chicago
Verification Date
September 2010