Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

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

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