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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005830
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Drug: cisplatin
Drug: doxorubicin hydrochloride
Procedure: adjuvant therapy
Procedure: radiation therapy
Phase I

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Cisplatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   53
Study Start Date:   July 2000

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005830

Locations
United States, Illinois
University of Chicago Cancer Research Center    
      Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center    
      Indianapolis, Indiana, United States, 46202-5289
United States, Ohio
Case Comprehensive Cancer Center    
      Cleveland, Ohio, United States, 44106
Lake/University Ireland Cancer Center    
      Mentor, Ohio, United States, 44060
United States, Washington
Fred Hutchinson Cancer Research Center    
      Seattle, Washington, United States, 98104
University Cancer Center at University of Washington Medical Center    
      Seattle, Washington, United States, 98195-6043

Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Jeffrey M. Fowler, MD     Arthur G. James Cancer Hospital & Richard J. Solove Research Institute    
Investigator:     Perry W. Grigsby, MD     St. Louis Children's Hospital    
Investigator:     William P. McGuire, MD     Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Fowler JM, Brady WE, Cohn DE, et al.: Sequential chemotherapy and irradiation in advanced-stage endometrial cancer: a Gynecologic Oncology Group phase I trial of doxorubicin-cisplatin followed by whole-abdomen irradiation. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-230, 2007.
 

Study ID Numbers:   CDR0000067844, GOG-9908
First Received:   June 2, 2000
Last Updated:   June 28, 2008
ClinicalTrials.gov Identifier:   NCT00005830
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III endometrial carcinoma  
stage IV endometrial carcinoma  
endometrial papillary carcinoma  
endometrial clear cell carcinoma  
endometrial adenocarcinoma  

Study placed in the following topic categories:
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Doxorubicin
Carcinoma
Genital Diseases, Female
Endometrial Neoplasms
Adenocarcinoma, Clear Cell
Cisplatin
Carcinoma, Papillary
Uterine Neoplasms
Endometrial cancer
Adenocarcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 09, 2008




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