Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00005830
First received: June 2, 2000
Last updated: August 19, 2013
Last verified: August 2013

June 2, 2000
August 19, 2013
July 2000
July 2009   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00005830 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer.

OBJECTIVES:

  • Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer.
  • Determine the acute and chronic toxic effects, in particular, severe and life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.

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

PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5 years.

Interventional
Phase 1
Masking: Open Label
Primary Purpose: Treatment
Endometrial Cancer
  • Drug: cisplatin
  • Drug: doxorubicin hydrochloride
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
Not Provided
July 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial cancer including 1 of the following subtypes:

    • Clear cell carcinoma
    • Serous papillary carcinoma
    • Endometrioid adenocarcinoma
  • Stage III or IV disease

    • Positive adnexa
    • Metastases to serosa, bowel mucosa, abdomen
    • Positive pelvic or paraaortic nodes
    • Positive pelvic washings or vaginal involvement within the radiation port
  • Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry

    • Must have had a hysterectomy and bilateral salpingo oophorectomy
  • No recurrent disease
  • No distant metastases outside of abdominopelvic area, including:

    • Parenchymal liver metastases
    • Lung metastases
    • Positive inguinal lymph nodes
    • Positive supraclavicular nodes
    • Pleural effusion with malignant cytology

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 no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and alkaline phosphatase no greater than 3 times ULN

Renal:

  • Creatinine no greater than ULN

Cardiovascular:

  • Cardiac ejection fraction greater than 50%

Other:

  • No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior pelvic or abdominal radiotherapy
  • No prior radiotherapy for other prior malignancy

Surgery:

  • See Disease Characteristics
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005830
GOG-9908, CDR0000067844, NCI-2012-02332
Yes
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Jeffrey M. Fowler, MD Ohio State University Comprehensive Cancer Center
Study Chair: Perry W. Grigsby, MD St. Louis Children's Hospital
Gynecologic Oncology Group
August 2013

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